QA Batch Release Assistant

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Since 1990, we have grown into a global leader in personalized medicine. Today, our +5,000 energetic employees are based in +80 locations in Europe, North America, South America, Africa and Asia-Pacific and are working together to support over 200,000 customers worldwide. From compounding and natural products to software, equipment, and genomics we deliver smart, ready-to-use solutions that make healthcare better. We are passionate, science-driven, and always looking for new ways to improve lives.

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 for required documentation in a pharmaceutical manufacturing setting, ensuring compliance to FDA regulations and plant procedures. The successful candidate will be able to manage multiple tasks and adjust priorities based on supply needs.

This position requires the ability to positively interact with multiple functional areas quickly and effectively resolve batch record documentation related issues, ensuring schedules are maintained and material is readily available.

• Reviews 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 reviews.
• Adheres to internal/external guidelines, specifications and regulatory requirements while reviewing batch documentation.
• Ensures all GMPs, Work Procedures and SOPs are followed.
• Identify exceptions and report them to production.
• Ensure deviations are initiated for any batch record review related events and find/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.
• Responsible for final batch disposition based on review of all associated documentation.
• Assist in resolving quality problems or 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 to all quality requirements.

• High School Diploma or Equivalent
• Excellent verbal and written communication skills
• Proficient in Microsoft Office
• Proficient in Microsoft Outlook
• College credits in biology, chemistry, or science-related courses

• Experience in manufacturing is preferred
• Knowledge of good documentation practices is preferred

Fagron offers its associates competitive salaries and a wide range of benefits including a 401(k) plan with a company matching contribution; medical, vision and dental; health savings account (HSA); holiday/paid time off.

We are proud to be an equal opportunity employer. Diversity makes us stronger, and we are committed to creating an inclusive workplace where everyone feels welcome.