Biological Critical Reagent (BCR) Specialist

Job Description

This position is responsible for managing the complete lifecycle of critical reagents (reference standards, positive controls, anti-sera, and other critical materials) used in the release and stability testing of vaccine and biological products. This includes but is not limited to acquisition, certification and qualification testing, implementation, and ongoing monitoring and replacement of the critical reagents as needed.

Essential Duties and Responsibilities

• Applies GMP/GLP in all areas of responsibility.
• Maintains critical reagent inventory and lifecycle documentation.
• Coordinates acquisition, qualification testing, implementation, storage, and replacement of critical reagents.
• Performs sample preparation, testing support, and routine data analysis associated with reagent qualification activities.
• Conducts second-person review of laboratory documentation and records.
• Documents work accurately and in accordance with regulatory requirements.
• Escalates quality events, deviations, and potential compliance concerns to leadership.
• Supports regulatory submissions and inspection readiness activities.
• Communicates effectively with internal and global stakeholders.
• Detects problems affecting work quality and brings them to management attention.
• Conducts all activities safely and efficiently.
• Performs other duties as assigned.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

This job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee. Duties, responsibilities, and activities may change at any time with or without notice.