About The Position
WHY PATIENTS NEED YOU At Pfizer, the impact you will have on improving patients' lives is profound. You will play a crucial role in navigating and interpreting the growing regulatory demands to ensure optimal patient care. Your expertise and commitment are crucial in adapting to these changes and maintaining the highest standards of patient care. Join us in our mission to make a global impact on patient care. WHAT YOU WILL ACHIEVE The Manufacturing Batch Record Reviewer provides support to clinical, commercial, and contract manufacturing operations. The role ensures adherence to regulatory expectations, safety, and GxP (i.e., Current Good Manufacturing and Documentation Practices). Duties include but are not limited to batch record review (both paper and eBR), ensuring necessary corrections are obtained and batch record finalization is completed by lead time attainment requirements. The secondee will work cross-functionally with manufacturing groups to perform compound/intermediate and final product batch record reviews and support Quality Assurance final disposition. HOW YOU WILL ACHIEVE IT Perform compound/intermediate and final product batch record review using computer software applications including, but not limited to: gLIMS, SAP, DeltaV, AMPS, MODA, Batch Tracker. Assess manufacturing operations/documentation to ensure proper execution and adherence to Procedures, Regulatory requirements, and Quality standard expectations. Assist with other tasks as needed such as: correction completion, batch tracker updates.
Requirements
- Applicant must have a bachelor's degree with 0+ years of experience; OR an associate's degree with 4 years of experience; OR a high school diploma (or equivalent) and 6 years of relevant experience.
- Fundamental knowledge of the principles and concepts of current Good Manufacturing Practices (cGMPs) used in the Pharmaceutical Industry.
- Knowledge of, and experience in a biopharmaceutical/pharmaceutical cGMP environment.
- Knowledge of electronic systems including SAP, gLIMS, DeltaV.
- Good judgment and correct decision making based on company procedures/standards, technical experience, and industry guidance / regulatory requirements.
- Collaboration skills and the ability to independently engage with a wide range of co-workers, customers, and management to gather input needed to complete assignments.
- Familiarity with the company's product ranges and ensuring regulatory compliance.
- This position requires permanent work authorization in the United States.
Responsibilities
- Perform compound/intermediate and final product batch record review using computer software applications including, but not limited to: gLIMS, SAP, DeltaV, AMPS, MODA, Batch Tracker.
- Assess manufacturing operations/documentation to ensure proper execution and adherence to Procedures, Regulatory requirements, and Quality standard expectations.
- Assist with other tasks as needed such as: correction completion, batch tracker updates.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Number of Employees
5,001-10,000 employees
