RN QAPI Coordinator- Reading
Company Name
**
Reading, PA, US
Basic
Posted 1 day ago
Overview
Full Time - Reading, PA
RN License Required
Currently seeking Reading, PA based QAPI to fill a full time, permanent, position at Senior LIFE. The ideal candidate will have healthcare quality assurance and process improvement experience, as well as a Bachelor's Degree.
Benefits of the QAPI Coordinator
Competitive Pay
Comprehensive Benefits Package
401k
Paid Time Off
Paid Holidays Off
Senior LIFE is an innovative home and community based Medicare and Medicaid funded program which provides all-inclusive healthcare services and support to seniors living in the community. Senior LIFE makes it possible for seniors to remain at home, enjoying the comfort and reassurance of familiar surroundings while receiving the care they need. Senior LIFE staff live the mission of the program. Our team is committed to partnering with our seniors to remain at home through promoting open communication and shared decision making while providing excellent care and services.
Responsibilities
Responsibilities of the QAPI Coordinator
Developing and implementing the quality improvement program for Senior LIFE
Creating and rolling out an annual review and update of the center’s quality improvement plan
Identifying and integrating quality indicators ;implementing tracking and review of best practices center-wide
Monitoring the open action/complaints hotline weekly, plus analyzing high level incident reports, infection control log and survey deficiencies to identify areas of improvement
Managing all data and providing comprehensive analytics and reporting, as needed
Educating and training staff on all aspects of quality improvement
Monitoring all new and existing initiatives, providing comprehensive analyses and improvement ideas and integrating those concepts in the short- and long-term
Conducting monthly facility orientations and provider network audits
Providing comprehensive assessments and QI recommendations to the Senior LIFE board of directors annually
Beyond immediate in-center responsibilities, this coordinator will have significant alignment with external governing bodies, including work with national quality management agencies and initiatives along with DPW. He/she will also service as the chairperson of the QA-PI committee and sit on the Senior LIFE Fraud, Waste and Abuse Compliance Committee.
Qualifications
This role requires a high level strategic thinker, able to quickly and effectively assess and analyze a situation, and successfully communicate appropriate next steps. Must hold active RN License. 2 years experience in healthcare, quality improvement experience preferred
EOE
Quality Assurance Analyst III
Company Name
**
St Inigoes, MD, US
Basic
Posted 3 days ago
Salary Statement Estimated Starting Salary Range: USD $111,100.00/Yr. - USD $185,100.00/Yr. Salary to be determined by the education, experience, knowledge, skills, and abilities of the applicant, internal equity, and alignment with market data.
Description
Supporting the Special Communication Mission Solutions (SCMS) Division at NAWCAD WOLF
FILLING THIS POSITION IS CONTINGENT UPON AWARD
#LI-TF1
Requirements
Bachelor's degree in an engineering, technical, or business discipline
Five years of Quality Assurance (QA) experience, at least two of those five years must include resource planning for quality assurance
Demonstrated experience conducting QA studies and evaluations and conduct work simplification andefficiency studies
Demonstrated experience preparing operations and procedures manuals to assist Government management to operate more efficiently and effectively
Demonstrated experience with compliance with ISO AS9100, Quality Management System (QMS) Aerospace, Defense, and Aviation organizations
Demonstrated experience reviewing, analyzing, and reporting status of compliance to the AS9100/ISOcertification, making recommendations to correct non-conformities and updating documents with approved resolutions
Demonstrated experience developing and implementing quality plans, procedures, and Standard Operating Procedures (SOPs) that conform to regulatorystandards
Demonstrated experience investigating processes and documentation problems and developing optimalcorrective actions for recurring discrepancies
Allowable bachelor's degree substitution is an associate's degree in an engineering, technical, or business discipline with at least 7 years of experience, at least two of those seven years must include resource planning for quality assurance
Secret Security Clearance required
Desired Skills
Providing Quality Assurance services at NAWCAD WOLF
Clearance Information
SRC IS A CONTRACTOR FOR THE U.S. GOVERNMENT, THIS POSITION WILL REQUIRE U.S. CITIZENSHIP AS WELL AS, A U.S. GOVERNMENT SECURITY CLEARANCE AT THE SECRET LEVEL
Travel Requirements
Less than five business days per calendar year
About Us
Scientific Research Corporation is an advanced information technology and engineering company that provides innovative products and services to government and private industry, as well as independent institutions. At the core of our capabilities is a seasoned team of highly skilled engineers and scientists with multidisciplinary backgrounds. This team is challenged daily to provide cutting edge technology solutions to our clients.
SRC offers a generous benefit package, including medical, dental, and vision plans, 401(k) with a company match, life insurance, vacation and sick paid time off accruals with amounts increasing based on role and years of service, 11 paid holidays, tuition reimbursement, and a work environment that encourages excellence and more. For positions requiring a security clearance, selected applicants will be subject to a government security investigation and must meet eligibility requirements for access to classified information.
EEO
Scientific Research Corporation is an equal opportunity employer that does not discriminate in employment.
All qualified applicants will receive consideration for employment without regard to their race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other protected characteristic under federal, state or local law.
Scientific Research Corporation endeavors to make www.scires.com accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact jobs@scires.com for assistance. This contact information is for accommodation requests only and cannot be used to inquire about the status of applications.
Senior Manager, Clinical Quality Assurance - Americas
Company Name
**
North Chicago, IL, United States
Basic
Posted 3 days ago
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on LinkedIn, Facebook , Instagram , X and YouTube.
This hybrid role could be based at any of AbbVie's location in the US such as North Chicago, IL Cambridge, MA, Worcester, MA Irvine, CA, San Francisco, CA or Florham, NJ
Purpose: As an independent RDQA Organization, our commitment is to drive quality excellence as a strategic advantage across all stages of discovery and development for the lifecycle of the product to achieve
product realization and to accelerate access to innovative therapies for our patients. AbbVie’s R&D
global trial footprint has been expanding due to growth in the pipeline and the complexity of global
development resulting in an overall increase in global trials in the Affiliates. In addition, the
acquisition of Allergan and integration with AbbVie have significantly increased clinical trials managed
from the Affiliates. RDQA AREA focuses on proactive quality and quality output in support of clinical
development/R&D enterprise within designated countries around the world.
AREA supports countries in Europe, Americas and Intercontinental as defined by AbbVie. The
expected results in the Affiliates are as follows; quality excellence, realization of R&D goals and
objectives for submission of new therapies including but not limited to adherence to One AbbVie
Quality System, execution of RDQA Quality System Excellence (CAPA, Change Management, Quality
Risk Management, Documentation Standards) and the assurance of integrity data. Scope includes
R&D and clinical research activities conducted by Affiliates or AbbVie within the region, to achieve
first pass approvals thereby advancing the pipeline.
This position will report to RDQA Associate Director or RDQA Global Director, AREA
Major Responsibilities:
The RDQA AREA Senior Manager will provide support for the assigned countries and region and will be responsible for the implementation/execution of activities related to proactive quality management. The following are key responsibilities: Maintain a close, collaborative relationship with RDQA functions impacting clinical research within designated Affiliates in the assigned countries and region. Establish collaborative-working relationship with clinical development leaders and staff within designated Affiliates to advance the AbbVie Quality System, drive quality excellence, and achieve first pass approval for market authorization by health authorities. Oversee quality and compliance in a regulated environment including AbbVie policies and procedures and country and regional standards and regulations. Lead and/or collaborate on development of risk identification and risk mitigation or control strategies for clinical research activities including clinical trials within designated countries with periodic reviews of quality and compliance data for the purposes of continuous improvement. Establish quality measures with the desire to achieve RDQA quality goals. Drive quality strategy in designated countries and region in conjunction with other RDQA AREA personnel. Manage governance/oversight that is “fit for purpose” and in relation to the One AbbVie Quality System. Identify trends, root causes, and potential risks to mitigate and/or prevent issues that impact clinical research. Drive vision of continuous state of regulatory preparedness. Ensure consistent understanding of the quality requirements for clinical research activities within Affiliates, works closely with Affiliates R&D Management on health of Quality System, identifies issues of quality and compliance that will impact overall goals and desired outcomes. Maintain awareness of all applicable regulations and develop appropriate standards to measure quality in assigned countries and region relating to clinical research. Support necessary supplier visits, audits and vendor qualifications Develop inspection strategy in collaboration with AREA Associate Director and relevant functions and provide inspection-readiness support for all local / regional Health Authority inspections. Provide oversight, support and follow-up (inspection report response) for local Health Authority inspections with employees and management in assigned countries and region. Participate in Health Authority inspections as needed. Determine need for country/process assessments/audits in collaboration with Clinical Audit and Clinical PM. Conduct audits as required to assess compliance with regulations, guidelines, policies and procedures and Sponsor requirements. Effectively communicate audit results, both orally and in writing. Review and approve corrective action plans/audit responses. Support the development of robust audit and inspection responses through coaching and education. Mentor AREA Managers/AREA Associates or line management as additional Lead responsibility
Bachelor's degree required preferably in Biology, Nursing, Pharmacy, or other medical science degree combined with equivalent technical experience. 8+ years of biopharmaceutical / medical device industry experience in quality assurance, compliance, regulatory affairs, clinical research and/or other related development functions that includes 3 years in in
leadership positions (people and/or initiatives/projects). Strong understanding of local and global regulatory and legal requirements and of the approach and perspectives of regulatory agencies. Ability to ensure strategic risk focus with evolving global regulations and expectations. Agile and able to respond rapidly to unplanned events and changing regulatory requirements and expectations. Thorough knowledge of quality systems, auditing standards and quality management. Motivates and can influence others, including those over whom they have no direct authority. Strong analytical skills with an ability to organize work in a logical, thorough & succinct manner. Ability to work at an experienced level, demonstrating effective leadership in interactions with business partners at all levels. Excellent written & oral communication skills including presentation and influencing skills. Strong negotiation, influencing and collaborating abilities with excellent networking skills. Ability to foster cross functional collaboration teams. Strong team player or team lead and builds relationships with peers and cross-functionally at both global and local levels to drive performance. Fluent in additional languages desirable but not required. Ability to travel as needed in AREA (up to 35%).
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. This job is eligible to participate in our long-term incentive programs. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html
Associate Director, Product Quality
Company Name
**
North Chicago, IL, United States
Basic
Posted 3 days ago
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on LinkedIn, Facebook , Instagram , X and YouTube.
Responsible for quality of assigned products which may include small molecule pharmaceuticals and/or biologics products, combination products, and medical devices to ensure business objectives are met with regards to on time delivery of product while assuring compliance to local, divisional, and corporate policies and external agency regulations worldwide. Products include regulatory starting materials, Active Pharmaceutical Ingredients (API), Intermediates, and Drug Products produced by AbbVie plants or by third-party manufacturers, In Licensing relationships, or Co-Marketing relationships. Acts as the primary quality representative for the global supply chain pertaining to external manufacturing business relationships and builds and maintains relationships with TPM Operations, Supplier Quality Management, TPM Business Alliance, Commercial, Global Supply Chain, Domestic and International AbbVie Plants and Affiliates, Regulatory Affairs, R&D, and S&T to ensure alignment on strategic in
Responsibilities
Lead a team of Quality professionals for product transfer activities and direct cross-functional team members to achieve on-time quality deliverables, high customer value, and profitable results. Ensures delivery of all quality elements needed to facilitate new product launches including Third Party Manufacturer’s that provide products directly to distribution centres, or to AbbVie domestic and International plants for further packaging and/or testing. Primary driver for the quality and complian Develops Global Product Quality Assurance strategy and implements agreed strategy to support pharmaceuticals, biologics, device and combination products produced at AbbVie plants as well as third party manufacturing (TPM) facilities. Primary Quality contact between third party manufacturers, R&D and AbbVie Operations in support of commercial operations, New Product Introductions and product transfers. Supports the regulatory filings and marketing authorization dossiers by developing and/or reviewing of chemistry, manufacturing and controls documents and Drug Master files/Certificate if suitability of monographs of the Ph. Eur. Documents. Lead QA contact with AbbVie Affiliates and Regulatory to prepare submissions and partic Makes key decisions on product quality, compliance and regulatory conformance issues for sterile, biological, liquid, solids, and/or device products and elevates medium and high risk events to AbbVie management. Leads the collection, verification and improvement of Quality metrics used for management review in partnership with senior leadership to develop a clear picture of overall compliance state and linking this to local / global project implementation. Leads product quality team to support development of the legal supply agreements, contractors or letters of intent to ensure that the appropriate quality, compliance and regulatory aspects are met for the products and services covered and manage the organisation’s actions within the legal boundaries of these documents. Ensures alignment of Quality and Technical Agreements with the legal contracts and that the commitments of the quality and technical agreements are being fulfilled. Helps facilita Establishes and maintains relationships and open communication with Third Party Manufacturers, AbbVie plants, affiliates and other functional groups to maintain roles and responsibilities, identify potential projects and issues, obtain an in-depth understanding of the quality, compliance, and resource needs at each site and provide guidance on quality concerns. Supports the management of exception documents and CAPA. Communicates and negotiates with external companies’ quality organization to maintain a consistent level of quality and a level of expectation that will minimize compliance risks but also balance the cost of operating to provide AbbVie with the agreed service. Prioritizes programs, initiatives, and problem solving with consideration for impact to timelines, resources and conflicting priorities. Manages team interfaces with Quality Assurance audit team to develop audit plans, due diligence plans, and inspection readiness plans, review audit observations and responses, and maintain corrective action timetable. Provides support for quality audits, initial site approvals and due diligence activities. Leads and manages pre-approval inspection readiness as related to the third party manufacturers to ensure regulatory approvals are obtained, with no delays to market entries. Core team member or lead of strategic programs; including Brand Teams, New Product Introductions, Product Transfers, Global Strategic Sourcing, Due Diligence, Site Selection, and Approvals and Continuous Improvement. Provides support and interfaces directly/indirectly with the FDA, EMA, MHRA, ANVISA, MoH, etc. for pre-approval inspections. Responsible for the strategic leadership of one or more division level quality systems to include SOP Development, Maintenance and Training. Develops, and/or implements the systems across AbbVie operations to assure consistent, high quality products and compliance with worldwide regulatory requirements. Develops new and improved Quality systems within Operations. Influences the decision making process to ensure quality requirements are included when improvement initiatives take place.
Bachelor’s Degree in relevant Life Science or other technical required. Graduate degree desired. Technical or Analytical background required for problem resolution with technical, quality, product and or engineering related issues. Total combined years of experience. Minimum of 10+ in Quality Assurance Operations Management, Regulatory, Operations, or Technical Support in a pharmaceutical setting. Required regulatory inspection experience with direct interaction with regulatory inspectors. Direct Plant experience in a pharmaceutical setting with a minimum of 5 years preferred. Knowledge and a comprehensive understanding of some biological and/or pharmaceutical technologies (sterile, biological, liquid, ointments, devices, solid tablets and caplets, suspensions, granulations, soft elastic capsules, gel caps, extended release products, coating solutions, and/or active pharmaceutical ingredients). Possesses knowledge and a skill set to operate within an environment that requires a high degree of urgency, strong analytical and problem solving skills, positive interpersonal skills, ability to manage multiple complex tasks simultaneously, and capable of performing as leaders, team members and individuals. Strong quality assurance / control, manufacturing, laboratory, technical support, regulatory, and / or validation background is required. A wide range of activities are undertaken from long term strategy development to short term crisis management. The incumbent must be capable of understanding and overcoming differing cultural and language obstacles to provide solutions that satisfy Corporate, Divisional, regional, and local objectives to effectively manage the action plans that will resolve the issues.
Experience working the requirements for third party external manufacturing.
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this postingbased on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more orless than the posted range. This range may be modified in the future.
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in our short-term incentive programs.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission,incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paidand may be modified at the Company’s sole and absolute discretion, consistent with applicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html
Maintenance Technician
Company Name
**
Florence, KY, United States
Basic
Posted 3 days ago
We Are Bosch.
At Bosch, we shape the future by inventing high-quality technologies and services that spark enthusiasm and enrich people’s lives. Our areas of activity are every bit as diverse as our outstanding Bosch teams around the world. Their creativity is the key to innovation through connected living, mobility, or industry.
Let’s grow together, enjoy more, and inspire each other. Work #LikeABosch
• Reinvent yourself: At Bosch, you will evolve.
• Discover new directions: At Bosch, you will find your place.
• Balance your life: At Bosch, your job matches your lifestyle.
• Celebrate success: At Bosch, we celebrate you.
• Be yourself: At Bosch, we value values.
• Shape tomorrow: At Bosch, you change lives.
Robert Bosch is hiring a Maintenance Technician in Florence, KY. As a Maintenance Technician, you will troubleshoot, repair, and perform preventative maintenance on electrical, hydraulic, pneumatic, and robotic systems, while supporting manufacturing operations through equipment reliability, PLC programming, and continuous improvement initiatives. This is a direct-hire opportunity.
Shift Information
Second & Third Shift Available
Principal Responsibilities of the Maintenance Technician
Troubleshoot, repair, and maintain electrical, hydraulic, pneumatic, and mechanical systems Perform preventative maintenance activities, including inspections, oil changes, lubrication, and equipment cleaning Maintain and improve the performance and precision of robotic and automated systems Diagnose issues with sensors, actuators, servo drives, and control systems Operate machine shop equipment such as lathes, grinders, and welding tools as needed Utilize diagnostic tools (multimeters, oscilloscopes, etc.) to identify and resolve equipment issues Support and implement PLC programming updates and system improvements Read and interpret blueprints, schematics, and technical documentation to support repairs and installations Monitor equipment performance and document maintenance activities and findings Collaborate with engineering and operations teams to improve system reliability and efficiency Maintain a clean, safe, and organized work environment in compliance with safety standards Working Conditions & Physical Requirements
Ability to work in a manufacturing environment with exposure to moving equipment and industrial conditions Ability to stand and walk for extended periods and perform repetitive movements such as bending, twisting, and lifting Ability to lift up to 45 pounds independently and move heavier items with assistance or lifting equipment Occasional work at heights and use of ladders
Required Qualifications
Associate degree in Industrial Maintenance, Mechatronics, Electrical Technology, or related field (or equivalent experience) Experience troubleshooting and repairing electrical, hydraulic, pneumatic, and mechanical systems in a manufacturing environment Working knowledge of PLC programming (Ladder Logic, STL, or similar) Ability to read and interpret electrical schematics, blueprints, and technical manuals Experience with servo systems, robotics, and automated equipment Familiarity with industrial electrical systems, including AC/DC circuits, motor wiring, and control wiring Strong troubleshooting skills with the ability to identify root causes and implement solutions Experience using diagnostic tools such as multimeters, oscilloscopes, and other testing equipment Strong mechanical aptitude and experience with preventative maintenance programs Ability to work in a fast-paced manufacturing environment and manage multiple priorities Preferred Qualifications
Experience with Siemens PLC systems (Step 7, TIA Portal, or similar platforms) Experience working with servo-hydraulic and electro-mechanical systems Familiarity with robotic systems and precision alignment processes
Equal Opportunity Employer, including disability / veterans
Indefinite U.S. work authorized individuals only. Future sponsorship for work authorization is not available.
*Bosch adheres to Federal, State, and Local laws regarding drug-testing. Employment is contingent upon the successful completion of a drug screen and background check. Candidates who have been offered the position must pass both screenings before their start date.
Your well-being matters at Bosch! We offer a competitive compensation and a benefits package designed to empower you in every area of your life. This includes premium health coverage, a 401(k) with generous matching, resources for financial planning and goal setting, ample paid time off, parental leave, and comprehensive life and disability protection. We're investing in your success!
FSQA Manager
Company Name
**
OSI-Geneva, IL, Geneva, Geneva, IL, United States
Basic
Posted 5 days ago
This role is responsible for leading all FSQA department activities and for developing and executing OSI’s food safety and quality strategy for our smaller/less complex plant facilities. This role works closely with operations and the NA FSQA team to drive OSI’s food safety culture in a very fast paced and customer driven environment.
Associate Director, Performance & Portfolio Management
Company Name
**
North Chicago, IL, United States
Basic
Posted 5 days ago
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on X , Facebook , Instagram , YouTube , LinkedIn and Tik Tok .
This position is based in North Chicago, IL (3 days onsite/2 days remote, 100% remote option is not available)
The Associate Director, Performance & Portfolio Management is a role within the Global Supply Chain Strategic Management Office (SMO). This role will lead and be accountable for the successful delivery of assigned process programs and projects, building the strategy and plan related to the strategic project and innovation portfolio, along with identifying and implementing operational excellence improvement projects/programs to support the entire function. The role will serve as a key contributor in end-to-end project/program objectives and outcomes, develop governance frameworks, especially driving efficiency and agility, and deliver new systems or system improvements to increase the success of the operations. This role will drive projects across the SMO and will provide various opportunities to communicate recommendations to senior-level leaders.
Responsibilities:
Lead the SMO performance & portfolio management team (including system owners) who will develop and manage as assigned key project artifacts such as project charters, status reports, work plans, stakeholder engagement plans and decision-making model. Responsible for compliance with applicable Corporate and Quality policies and procedures and developing governance frameworks for resource allocation and investment decision. Build and maintain collaborative and trusted relationships at all levels within the organization by understanding business needs and providing exceptional project management leadership to advance strategic priorities. Recommend improvement opportunities and implement departmental initiatives to increase effectiveness—ensure resource capacity and capability alignment with strategic priorities. Strategize with and advise project sponsor/business lead regarding project direction and decisions. Provide strategic project advisory to enable successful outcomes leading to agility and efficiency—promote transparency and accountability through robust tracking and communication. Manage the entire lifecycle of projects including driving team accountabilities, addressing project issues/risks, driving effective decision making and delivering status updates/recommendations to function head or senior management. Work with functional leaders to propose new projects to continue to enhance productivity, compliance and efficiencies within their functions. Proactively identify and implement opportunities to optimize project team effectiveness and outcomes such as creating and distributing performance scorecards and dashboards to monitor initiative progress and value, or identify underperforming initiatives and recommend actions for recovery or pivot. Responsible at the program level to ensure key projects are delivered effectively (meeting the business needs) and on time. Maintain and update the master project list, aligning with enterprise priorities.
Bachelor’s degree at a minimum, advanced degree or equivalent experience preferred 10 + years project management experience and/or business excellence methodologies within global companies, working on large cross-functional strategic and operations initiatives. Project management certification(s) preferred (e.g. Lean Six Sigma certification(s), Project Management Institute (PMI) Project Management Professional (PMP) certification) Proven Success in a leadership role with strong leadership/management skills. Strong communication skills, both orally and written Demonstrated ability to lead/influence global multi-functional teams Proven project planning and management experience including successful implementation of business and technology initiatives (ideally within supply chain, operations, manufacturing, or an enterprise transformation environment) Experience working a global, complex and matrix environment
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in our short-term incentive programs.
This job is eligible to participate in our long-term incentive programs
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html
Manager, Business Systems Owner
Company Name
**
North Chicago, IL, United States
Basic
Posted 6 days ago
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on LinkedIn, Facebook , Instagram , X and YouTube.
This role is responsible for capability leadership relating to Sample Management (Analytical/Micro/Environmental), Stability Study Operations, Reference Standard Management and Lab Inventory Management for various AbbVie QA labs at our more complex, larger sites. A successful candidate will develop multi-year strategies, roadmaps and bring an innovative technology mindset to support the planning of innovative laboratory solutions to drive improved business outcomes. QA Lab Business Owner works closely with: IT Manager and project managers, Manufacturing Sites and the broader Lab organization globally to conduct advanced business analysis, evaluation, development and execution of a robust solutions to meet the needs of Global Lab Operations and evolving technology.
Responsibilities
Develops and promotes business cases for key projects. Responsible for planning and overseeing and execution of a portfolio of technology projects from ideation to completion; including securing cross-functional alignment on project scope, benefits, cost, and timelines. He/she is expected to work effectively across various IT shared services teams, manufacturing site representatives, and Global QA Lab stakeholders. Provides management oversight and implementation of projects capping in excess of 14 million dollars. Ensures technology strategy and roadmaps for portfolio of solution enables business objective usability while optimizing the total cost of ownership for IT solutions and ensuring compliance to applicable regulations Collaborates with local teams and solution vendors to minimize impact to production, ensure continuity of business solutions, assure alignment with architecture & technology standards, and ability of product scale to meet AbbVie requirements. Communicates and educates the technical and business communities on current architectures and technologies. Identify current and emerging business needs and evaluates technology solutions to balance short term and long-term objectives. Understands both data and technology capabilities already in use across AbbVie and recommends and implements appropriate solutions. Accountable for financial objectives and timelines of the portfolio, including monthly targets, project targets and overall implementation and maintenance while supporting a dynamic manufacturing portfolio. Builds positive culture and develops team members while overseeing the department. Monitors team workload, guides team through complex work issues, and answers questions. Interviews, hires, and recommends salary adjustments for team members as needed. Collaborates with team members to establish performance goals, conducts performance reviews, and assists with succession planning.
Bachelor’s Degree or an equivalent combination of education and work experience. Minimum of 10 years of work experience including laboratory background, business analysis, project management, and strategic execution. Self-Directed Leader, quickly grasping business needs and setting direction and implementation. Excellent analytical, judgment and consultative capabilities and communication skills Excellent communications and influencing skills with strong ability to balance differing stakeholder interests through sound analysis and persuasion Lab Systems / Lab Experience is required (LIMS, ELN, CDS, Inventory, Asset Management).
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. This job is eligible to participate in our long-term incentive programs. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html
Senior Quality Specialist: Medical Device
Company Name
**
Lancaster, PA, United States
Basic
Posted 9 days ago
Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.
The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. It also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products.
In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.
Job Description
Applies GMP/GLP/ISO IEC 17025 in all areas of responsibility, as appropriate Perform internal quality assurance audits Review client or agency documents and identify requirements outside our usual practices, communicate to technical operations, assist with implementing appropriate changes Perform review and approval of SOP's Keep abreast of regulatory or industry quality assurance (QA) requirements, consult with clients or regulatory authorities regarding any special QA requirements they may have, assist technical operations with application and interpretations Provide information and revision support for updating company publications including quality policy manuals, company web site, and newsletters Identify and drive system improvements, both within the department and for laboratory operations; determine the most effective way to accomplish a goal or strategy; suggest improvements to maximize quality and productivity Demonstrate skill in using the computer to access information, perform job functions (e.g., spreadsheets, power point), and prepare other reports Perform data review (analytical, validation, investigations), review for compliance and identify issues, provide options for resolution Review QC data and non-conformance issues for assigned technical groups, evaluate for trends or patterns Investigate and document QA, method, and regulatory deficiencies within the lab; take investigation to next level when needed; diagnose and solve problems independently Implement and document computer program changes, review computer system documents, provide feedback to meet regulatory and industry expectations
Qualifications
The Ideal Candidate would possess:
Strong computer, scientific, quality orientation, and organizational skills Excellent communication (oral and written) and attention to detail Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies Word processing, spreadsheets, PowerPoint, and database experience Previous GMP, Root Cause Analysis, and technical writing experience Minimum Qualifications:
Bachelor's degree in a science-related field or equivalent directly-related experience (two years of directly related industry experience is equivalent to one full-time year of college in related major) Minimum three years of laboratory experience with knowledge of regulatory requirements Authorization to work in the United States indefinitely without restriction or sponsorship
Position is Full-time, Monday-Friday, 8 a.m.-5 p.m. , with overtime as needed. Candidates currently living within a commutable distance of Lancaster, Pennsylvania are encouraged to apply.
Excellent full-time benefits including:
Comprehensive medical coverage, dental, and vision options Life and disability insurance 401(k) with company match Paid vacation and holidays #LI-EB1
Eurofins USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.
Senior Construction Field Inspector
Company Name
**
Hunt Valley, MD, United States
Basic
Posted 10 days ago
Work with Us. Change the World.
At AECOM, we're delivering a better world. Whether improving your commute, keeping the lights on, providing access to clean water, or transforming skylines, our work helps people and communities thrive. We are the world's trusted infrastructure consulting firm, partnering with clients to solve the worldâs most complex challenges and build legacies for future generations.
There has never been a better time to be at AECOM. With accelerating infrastructure investment worldwide, our services are in great demand. We invite you to bring your bold ideas and big dreams and become part of a global team of over 50,000 planners, designers, engineers, scientists, digital innovators, program and construction managers and other professionals delivering projects that create a positive and tangible impact around the world.
We're one global team driven by our common purpose to deliver a better world. Join us.
The Transportation Business Line of AECOM is actively seeking experienced Senior Construction Field Inspectors to support large-scale transportation infrastructure projects throughout the Baltimore area. These roles will involve field inspection services on complex projects, including roadway, bridge, and other transportation improvements, with a focus on quality, safety, and compliance with project plans, specifications, and regulatory requirements.
Responsibilities include but are not limited to:
Conduct pre-construction meetings and participate in regular project meetings Ensure proper implementation of environmental protection measures and erosion control practices Maintain accurate and organized project files, including photographs, correspondence, and technical data Manage inspection staff Stay updated on industry standards, regulations, and best practices in construction inspection Mentor and provide guidance to junior inspectors as needed Inspection of construction sites to ensure compliance with plans, specifications, and safety regulations Identify and document non-conformances to plans and specifications Review Plans and Construction Documentation Perform material testing and inspection on materials and equipment to ensure compliance with plans and specifications Prepare detailed daily inspection reports Communicate effectively with project managers, contractors, and other stakeholders regarding inspection findings Collaborate with the Project Team to resolve construction issues to ensure timely project completion Monitor and report on project progress, including schedule adherence and milestone achievements
Minimum Requirements:
High School Diploma or GED plus 6 years of related experience, or demonstrated equivalency of experience and/or education Experience on transportation-related projects, including roadways, bridges, rail, and tunnels U.S. Citizenship is required, due to the nature of the work Certified in concrete testing, compaction (asphalt, soils, and aggregate), E&S, and work zone MOT Knowledge of construction plans, standards, specifications, and regulations Proficiency in using inspection tools and applications Preferred Qualifications:
NICET (any level) Bachelor’s degree in Civil, Structural, Geotechnical, Environmental, Electrical, Mechanical, or Industrial Engineering, or Construction Management 10 years of experience on transportation related projects (roadways, bridges, rail, tunnels) and have a H.S. Diploma or equivalent Demonstrated attention to detail with the ability to identify and resolve problems effectively Strong communication and interpersonal skills Ability to work independently and as part of a team Strong working knowledge of Microsoft Office and the ability to learn new applications as required
Relocation assistance is not available for this position
Sponsorship for US employment authorization is not available now or in the future for this position
As a condition of employment, candidate must pass client required background check(s).
At AECOM, we are committed to maintaining a secure and trustworthy recruitment process and take any fraudulent hiring activity seriously. To support this commitment, all newly hired employees are required to attend an in-person Day 1 onboarding at an AECOM office location as a condition of employment.
About AECOM
AECOM is proud to offer comprehensive benefits to meet the diverse needs of our employees. Depending on your employment status, AECOM benefits may include medical, dental, vision, life, AD&D, disability benefits, paid time off, leaves of absences, voluntary benefits, perks, flexible work options , well-being resources, employee assistance program, business travel insurance, service recognition awards, retirement savings plan, and employee stock purchase plan.
AECOM is the global infrastructure leader, committed to delivering a better world. As a trusted professional services firm powered by deep technical abilities, we solve our clients’ complex challenges in water, environment, energy, transportation and buildings. Our teams partner with public- and private-sector clients to create innovative, sustainable and resilient solutions throughout the project lifecycle – from advisory, planning, design and engineering to program and construction management. AECOM is a Fortune 500 firm that had revenue of $16.1 billion in fiscal year 2025. Learn more at aecom.com.
What makes AECOM a great place to work
You will be part of a global team that champions your growth and career ambitions. Work on groundbreaking projects - both in your local community and on a global scale - that are transforming our industry and shaping the future. With cutting-edge technology and a network of experts, you’ll have the resources to make a real impact. Our award-winning training and development programs are designed to expand your technical expertise and leadership skills, helping you build the career you’ve always envisioned. Here, you’ll find a welcoming workplace built on respect, collaboration and community—where you have the freedom to grow in a world of opportunity.
As an Equal Opportunity Employer, we believe in your potential and are here to help you achieve it. All your information will be kept confidential according to EEO guidelines.
Product Quality Senior Manager (Science)
Company Name
**
North Chicago, IL, United States
Basic
Posted 10 days ago
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on LinkedIn, Facebook , Instagram , X and YouTube.
Responsible for quality of assigned products which may include small molecule pharmaceuticals and/or biologics products, combination products, and medical devices to ensure business objectives are met with regards to on time delivery of product while assuring compliance to local, divisional, and corporate policies and external agency regulations worldwide. Products include regulatory starting materials, Active Pharmaceutical Ingredients (API), Intermediates or Drug Products produced by AbbVie plants or by third-party manufacturers, In Licensing relationships, or Co-Marketing relationships. Develops in concert with Regulatory Affairs, the appropriate regulatory strategies for product brands. Grade is commensurate on level of overall responsibility.
Responsibilities
Maintains the primary quality lead with management oversight for project activities and the team members (within and outside of AbbVie) to achieve on-time quality deliverables, high customer value, and profitable results. Primary driver for the quality and compliance aspects of product transfers and organization optimization. Participates in the development of global Product Quality Assurance strategy to support pharmaceuticals, biologics, device and combination products produced at AbbVie plants as well as third party manufacturing (TPM) facilities. Implements agreed strategy. Performs final quality release of manufactured product lots for products and/or product lines prepared by Third Party Manufacturers. Makes recommendations for key decisions on product quality and compliance and regulatory conformance issues for sterile, biological, liquid, solids, and/or device products and elevates medium and high risk events to AbbVie management. Ensures alignment of Quality and Technical Agreements with the legal contracts and that the commitments of the quality and technical agreements are being fulfilled. Helps facilitate resolution in cases where they are not. Establishes and maintains relationships and open communication with Third Party Manufacturers, AbbVie plants, affiliates and other functional groups to maintain roles and responsibilities, identify potential projects and issues, obtain an in-depth understanding of the quality, compliance, and resource needs at each site and provide guidance on quality concerns. Communicates and negotiates with external companies’ quality organization to maintain a consistent level of quality and a level of expectation that will minimize compliance risks but also balance the cost of operating to provide AbbVie with the agreed service. Prioritizes programs, initiatives, and problem solving with consideration for impact to timelines, resources and conflicting priorities. Interfaces with Quality Assurance audit team to develop audit plans, due diligence plans, and inspection readiness plans, review audit observations and responses, and maintain corrective action timetable. Provides support for quality audits, initial site approvals and due diligence activities. Leads and manages pre-approval inspection readiness as related to the third party manufacturers to ensure regulatory approvals are obtained, with no delays to market entries. Contributes to Quality Assurance elements needed to facilitate new product launches including Third Party Manufacturer’s that provide products directly to distribution centers, or to AbbVie domestic and International plants for further packaging and/or testing. Coordinates activities to support follow-up on compliant trend investigations for non-medical and medical (adverse events). Supports the management of exception documents and Corrective and Preventive Actions. Completes management reviews with assigned Third Party Manufacturers that identify and address quality, operational, and organizational issues. Obtains and reviews summaries of the Annual Product Reviews (domestic) and Annual Product Quality Reports (EU) from the Third Party Manufacturer to ensure accuracy, completeness, timeliness, and trends are identified and addressed in an appropriate manner.
Bachelor’s Degree in relevant Life Science, Engineering, or other technical discipline required. Technical or Analytical background required for problem resolution with technical, quality, product and or engineering related issues. Total combined years of experience. Minimum 8+ years. At least 3 years in Quality Assurance Operations Management; 5+ years in any of the following areas; Operations, Research and Development, Regulatory or Consulting. Direct Manufacturing Plant experience in a Pharmaceutical setting is preferred. Knowledge and a comprehensive understanding/expertise of some biological and/or pharmaceutical technologies (sterile, biological, liquid, ointments, devices, solid tablets and caplets, suspensions, granulations, soft elastic capsules, gel caps, extended release products, coating solutions, and/or active pharmaceutical ingredients). Strong quality assurance/control, manufacturing, laboratory, technical support, regulatory, and/or validation background is required. Experience with FDA and other regulatory agency interactions and inspections is required. Familiarity with the requirements for third party external manufacturing. Possesses knowledge and a skill set to operate within an environment that requires a high degree of urgency, strong analytical and problem solving skills, positive interpersonal skills, ability to manage multiple complex tasks simultaneously, and capable of performing as leaders, members and individuals.
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location ,and we may ultimately pay more or less than the posted range. This range may be modified in the future.
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in our long-term incentive programs.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission,incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless anduntil paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html
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