Specialist, Client QA

Specialist, Client QA

Position Summary

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.
Catalent’s Harmans/BWI, MD facility is a FDA-licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies. The campus features two manufacturing facilities: 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.

Catalent’s Harmans/BWI, MD facility is a FDA-licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies. The campus features two manufacturing facilities: 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 is responsible for providing QA support and oversight of Client Projects from start to finish for GMP Manufacturing of master/working cell banks, biological bulk drug substance and finished drug product.  Client QA serves as the dedicated Client QA Representative and liaisons with the Client and other functions including Project Management, Process Development, Technology Transfer, Manufacturing, Quality Control and other functions within the Quality Assurance unit. Responsibilities include tracking and reviewing technology transfer documents, specifications, master batch records, change requests, deviations and failure investigations supporting the release of manufactured material. 

This position is 1st shift Monday-Friday 8AM-5PM and is 100% on site at BWI/Harmans, MD facility.

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:

• Provides dedicated QA support to client projects and client interactions & meetings; involved from inception of a client’s project until project closure. Supports Clinical and Commercial QA activities, including initial process development and non-clinical batch production.
• Tracks, documents and presents Quality Metrics presentations for Client Projects (on time batch release, right first time, deviations per batch); works with clients during initial and subsequent manufacturing campaigns 
• Provides quality oversight of GMP operations for the manufacture of master/working cell banks, bulk drug substance and/or final drug product; conducts review of master batches record during Technical Transfer for client processes 
• Supports GMP departments in reviewing and approving deviations and failure investigations, including root cause analysis, evaluating product/facility impacts, and evaluating effective corrective and preventive actions (CAPAs); performs risk analysis and mitigation, using available tools such as FMEA, when needed. 
• Maintains databases and systems used for tracking various GMP manufacturing associated support activities; assists with the review and approval of GMP documentation such as Standard Operating Procedures 
• Supports regulatory (i.e. FDA, EMA) and client audits/inspections; assists with internal audits of GMP systems and facilities 
• Works cross-functionally with Project Management, Pre-Clinical Services, Manufacturing, Facilities, Quality Control and other departments to resolve quality issues and provide assistance when needed 
• Actively participates in training act