Candidate will work as a Quality Assistant to 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 cGMP’s to ensure timely release of batches.
• Execute batch record review and review of supporting systems, to include LUMAC review.
• Adheres to internal/external guidelines, specifications and regulatory requirements while reviewing batch documentation.
• Ensures all GMP’s, Work Procedures and SOP’s are followed.
• Identify exceptions and report exceptions to production.
• Ensures deviations are initiated for any batch record review related events. Find and communicate deviations to appropriate department for investigation.
• Effectively resolve documentation discrepancies and issues with manufacturing operations personnel in a timely manner to allow for material release.
• Addresses deficiencies and ensures 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/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 aspect of the material release process by maintaining compliance to all quality requirements.
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Set Yourself Apart: Profile/Experiences
• 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 is preferred
• Experience in manufacturing is preferred
• Knowledge of good documentation practices is preferred
Fagron offers exciting opportunities for personal and professional growth. We provide an open and truly dynamic environment which supports and encourages you to develop your skills and talents.