Lead Technician, Batch Disposition

Lead Technician, QA – Batch Disposition

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.

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 Lead Technician, QA – Batch Disposition is responsible for providing QA Operations support on maintaining, filing and scanning of batch records and supporting documentation. This role is also responsible for the timely data entry and maintenance of batch review life cycle tracker and visual boards.

This is a full-time on-site position, Monday - Friday 9am - 6pm.

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

• Responsible for the organization and maintenance of executed manufacturing batch records and supporting GMP documentation to support batch disposition

• Review of terminated, discontinued and rejected batch records and other GMP documents as applicable.

• Responsible for the accurate and efficient systems to storage, cataloging and retrieval of in-process GMP documents directly supporting batch disposition.

• Conduct training for QA employees on efficient system usage.

• Uploads GMP documents into designated network locations for review and retrieval

• Responsible for in-process GMP document security and tracking

• Responsible for accurately maintaining batch record status database and visual board.

• Communicate effectively and frequently with personnel to obtain information necessary to maintain tracking tools up to date.

• Actively participates in training activities, managing their individual training plan.

• Other duties as assigned.

The Candidate

• High school diploma and minimum of 3 years’ experience within biologics, biopharmaceuticals, or a regulated industry.

• Knowledge of using an EDMS and ability to create workflows and reports from these systems 

• Knowledge of Good Manufacturing Practices (GMPs) and 21 CFR part 11

• Hands on experience with an EDMS creating documents for a GMP environment.

• Expert in formatting in Microsoft Word and use of edit tools.

• Good communication skills and ability to work in a group setting where priorities may be shifted weekly

• Ability to work in a cross functional team and escalate concerns related to priorities and patient first concepts

• Requires the ability to produce results in a fast-paced environment to meet client deadlines

• Positive, professional attitude toward work and willingness to cooperate with co-workers and supervisors and to contribute to the team 

• Timeliness and accuracy in completion of projects and paperwork (quantity and quality of work) 

• Identification of problem areas affecting workload expectat