QA Batch Release Assistant; 1st Shift

About the Job

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 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/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

• 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

We offer a dynamic environment where talent and ambition can develop to its fullest. We have an open and informal organization culture, where individuals need to have strong motivation and ability to work independently. Fagron is a widely expanding, international, professional and ambitious pharmaceutical company with multiple growth opportunities. Job opportunity includes competitive salary, comprehensive benefits, performance package, and ability to be part of an international leader in an expanding industry.

Fagron North America is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law.