QA Batch Release Assistant
Fagron Sterile Services US (FSS), Wichita, KS, United States
The Batch Release Assistant will perform a timely and efficient cGMP and quality review of batch record documentation to ensure prompt batch disposition and release. This person will serve as reviewer and/or approver in a pharmaceutical manufacturing setting, ensuring compliance with FDA regulations and plant procedures. The successful candidate will be able to manage multiple tasks, adjust priorities based on supply needs, and positively interact with multiple functional areas to resolve batch record documentation related issues, keeping schedules on track and ensuring material is readily available.
Key Responsibilities
Review all batch documentation for accuracy and completeness according to cGMPs to ensure timely release of batches.
Execute batch record review and review of supporting systems, including LUMAC review.
Adhere to internal and external guidelines, specifications, and regulatory requirements while reviewing batch documentation.
Ensure all GMPs, Work Procedures, and SOPs are followed.
Identify exceptions and report them to production.
Initiate deviations for any batch record review related events and communicate deviations to the appropriate department for investigation.
Effectively resolve documentation discrepancies and issues with manufacturing operations personnel in a timely manner to allow for material release.
Address deficiencies and ensure timely completion of all follow‑up actions for resolution to all batch review issues according to GMP standards.
Take responsibility for final batch disposition based on review of all associated documentation.
Assist in resolving quality problems and concerns related to batch review.
Work proactively on a daily basis to ensure schedules are maintained and material is readily available.
Build quality into all aspects of the material release process by maintaining compliance with all quality requirements.
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Key Responsibilities
Review all batch documentation for accuracy and completeness according to cGMPs to ensure timely release of batches.
Execute batch record review and review of supporting systems, including LUMAC review.
Adhere to internal and external guidelines, specifications, and regulatory requirements while reviewing batch documentation.
Ensure all GMPs, Work Procedures, and SOPs are followed.
Identify exceptions and report them to production.
Initiate deviations for any batch record review related events and communicate deviations to the appropriate department for investigation.
Effectively resolve documentation discrepancies and issues with manufacturing operations personnel in a timely manner to allow for material release.
Address deficiencies and ensure timely completion of all follow‑up actions for resolution to all batch review issues according to GMP standards.
Take responsibility for final batch disposition based on review of all associated documentation.
Assist in resolving quality problems and concerns related to batch review.
Work proactively on a daily basis to ensure schedules are maintained and material is readily available.
Build quality into all aspects of the material release process by maintaining compliance with all quality requirements.
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