Quality Management Jobs

Company Overview Creating a Healthier World through Accessible Biologics: Kashiv BioSciences, LLC is a fully integrated biopharmaceutical company. Kashiv BioSciences, LLC in the United States, and its subsidiary, Kashiv BioSciences Private Limited in India (together “Kashiv BioSciences”), operate together with robust infrastructure and highly skilled teams that provide global R&D, clinical, manufacturing, regulatory, and IP capabilities. We believe our people, partners, and shared purpose fuel our work to advance patient care and access to important medicines. Position Summary The Documentation Specialist I is a regular employee in a full-time position at Kashiv BioSciences, LLC, in Chicago, IL. The employee is responsible for assisting with the review, issuance, control, formatting, reconciliation, and archival of procedures, forms, test methods, and related controlled documents throughout the organization. The Documentation Specialist I will also support maintenance of employee training files and training curricula to help ensure employees remain current in assigned training. Essential Duties & Responsibilities Assist with issuing and controlling, but not limited to, Master Batch Records, Controlled Forms, Logbooks, Test Methods, Protocols, and Reports. Assist with issuing and routing Document Change Requests (DCRs) in the Electronic Document System. Scan batch records, validation documentation, calibration information, and supporting documentation, and post to the company portal as needed. Assist with auditing issued Controlled Forms, Master Batch Records, and Logbooks to support reconciliation and timely return of documents for final archival. Receive documentation and ensure documents are properly archived and easily retrievable. Ensure documents are properly formatted. Assist with template management to support harmonization among documents within the organization. Assist with tracking lead times for Document Change Requests. Provide routine status updates for pending document reviews in the Electronic Document System, as requested. Provide basic user support for the documentation system, including creation and monitoring of incident tickets requiring help desk support from the Electronic Document System Administrator. Assist change originators with coordination of document releases. Support implementation of efficiency improvements to the overall document control process. Assist the training team by tracking training files and completion of training modules. Upload PDF versions of procedures to the corporate portal. Support assigned projects and activities to meet the needs of Quality Management. Perform other duties and responsibilities as delegated by Quality Management.