Batch Release Specialist

4 weeks ago


Harmans, Maryland, United States Catalent Inc Full time
About Catalent Inc

Catalent is a global company that partners with the pharmaceutical industry to develop and manufacture new treatments for patients worldwide.

Our mission is to help people live better, healthier lives. We have a state-of-the-art CGMP manufacturing facility located on the Harmans/BWI campus, which is close to Washington, DC's I-270 Technology Corridor, top universities, and government agencies.

The Role

We are seeking a Senior Specialist, Batch Disposition to provide Quality Assurance support for GMP documentation of master/working cell banks, bulk drug substance and finished drug product.

This includes reviewing executed batch records, master batch records, product labels, SMPs, and product specific documents to ensure compliance with good documentation practices (GDP) and cGMP regulations.

The ideal candidate will have a strong background in biologic, biopharmaceutical, or regulated industry, with knowledge of Good Manufacturing Practices (GMPs), 21 CFR Parts 210, 211, biological regulations per 21 CFR Parts 600s, ICH Guidelines and EU GMPs.

The salary range for this position in Maryland is $93,280-$128,260 plus annual bonus, when eligible.

Benefits

Catalent offers competitive medical benefits and 401K, 152 hours of PTO + 8 Paid Holidays, dynamic work environment, opportunity to work on Continuous Improvement Processes.



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