Specialist, QA Batch Disposition

Position Summary Catalent is a global, high-growth, public company and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives. Our FDA-licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies is located on the Harmans/BWI campus. The campus, featuring two manufacturing facilities is located 5 miles from the Baltimore Washington International (BWI) airport and 13 miles from our Baltimore location. The campus is close to Washington, DC’s I-270 Technology Corridor, top universities, and government agencies. The Harmans/BWI-1 EMA and FDA approved facility, at approximately 200,000 sq. ft., houses 10 CGMP manufacturing suites, fill/finish, central services, testing labs, and a warehouse. The Harmans/BWI-2 facility, at approximately 145,000 sq. ft., is under development and will house 8 CGMP manufacturing suites and cold storage warehousing. Both facilities support Phase 3 through commercial manufacturing of advanced therapeutic products including AAV and other viral vector-based therapies and vaccines. The Specialist, QA – Batch Disposition is responsible for providing Quality Assurance support for GMP documentation of master/working cell banks, bulk drug substance and finished drug product. Responsibilities include but are not limited to GMP documentation review and supporting other QA functions as needed. In this role, the Specialist, QA – Batch Disposition is responsible for continuously monitoring systems and procedures to ensure compliance with applicable regulatory and industry standards, and to identify areas of opportunity and quality improvements. This is a full-time on-site position, Monday – Friday 8:30am – 5:30pm. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee. The Role Review documentation for manufacturing activities associated with commercial, development, and engineering execution in accordance with good documentation practices (GDP), including but not limited to: executed batch records, master batch records, product labels, SMPs, and product specific documents. Interacts with the quality team and internal stakeholders to support the development, manufacturing, testing, packaging, and release of cell and gene therapy products. Independently executes batch record review for completeness, accuracy and cGMP compliance. Support the evaluation and lot disposition of intermediates, finish bulk drug substance and drug product. Critically review various documentation types to ensure completeness, accuracy and compliance including but not limited to test methods, method validation protocols and reports and SOPs. Contributes to process improvement of batch records and associated processes (e.g. turnaround times) to ensure all QA batch disposition deadlines are met. Act as QA reviewer for investigations, deviations and CAPAs appropriate and designated by QA Management. Collaborates within Manufacturing to resolve batch record discrepancies or errors as it relates to Good Documentation Practices or Manufacturing Execution System (MES) inventory. Other duties as assigned. The Candidate Masters’ degree with 0 years of experience. Life Science discipline degree preferred. OR Bachelors’ degree with minimum 2 years’ experience. Life science discipline degree preferred. Intermediate knowledge base with Good Manufacturing Practices (GMPs), 21 CFR Parts 210, 211, biological regulations per 21 CFR Parts 600s, ICH Guidelines and EU GMPs. Intermediate knowledge to biological manufacturing processes including microbial and cell culture cell banking, fermentation/cell culture, purification and fill/finish. Able to work in a team setting and independently under minimum supervision. Intermediate knowledge with electronic systems, including developing and producing reports using Microsoft Office (Excel). Intermediate technical and quality background related to pharmaceuticals. Timeliness and accuracy in completion of projects and paperwork (quantity of work).

Salary : $52,000 - $92,000