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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.
Job Responsibility:
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
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
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 is preferred
Experience in manufacturing is preferred
Knowledge of good documentation practices is preferred
Nice to have:
College credits in biology, chemistry, or science related courses is preferred
Experience in manufacturing is preferred
Knowledge of good documentation practices is preferred
What we offer:
competitive salary
comprehensive benefits
performance package
ability to be part of an international leader in an expanding industry