What are the responsibilities and job description for the QA Document Control Analyst position at University of Pennsylvania?
Overview
- Reporting to the Quality Assurance Manager, the Quality Assurance Analyst, GMP Doc Control plays a critical role in supporting the quality operations of the Clinical Cell and Vaccine Production Facility (CVPF) for the aseptic manufacture of novel cell and gene therapies. The QA Analyst, Doc Control will primarily be responsible for managing the CVPF’s document management system (Veeva QualityDocs), updating and issuing batch records, and maintaining the training program (Veeva Learning Management System (LMS)). This role is pivotal as it works closely with the Clinical Operations team to ensure batch records are released as quickly as possible once enrolled patients are confirmed for upcoming manufacturing slots. The QA Analyst, GMP Doc Control also ensures all CVPF staff are fully trained in the most current procedures to guarantee all cell therapy products are manufactured to the highest quality and regulatory standards. In addition to these responsibilities, the incumbent will also assist the rest of the QA team in management and improvement of the QMS.
- The CVPF is accredited by the Foundation for the Accreditation of Cellular Therapies (FACT) which includes an on-site inspection every 3 years and annual renewal applications. The CVPF also supports external biotech companies as a Contract Manufacturing Organization (CMO) who periodically audit the CVPF for compliance with cGMPs and contracted terms. The QA Analyst, GMP Doc Control will play a pivotal role in these activities.
Responsibilities
- Assist QA Specialists with the day-to-day operation of the Document Control System and training program.
- Update master batch records and issue all requested production copies as requested by QA Specialists.
- Developing expert knowledge of document management and training systems.
- Assisting QA specialists with document revision processes and periodic review of documents.
- Assisting QA specialists with the CVPF training program.
- Review any procedures related to this subject matter area.
- Maintain employee training binders.
- Send and retrieve documents from off-site storage as requested by QA specialists and other functional groups.
- Compile training metrics.
- Support regulatory and client inspections.
- Mediate any lack of document management efficiency or effectiveness.
Qualifications
- Bachelor’s degree with at least 1-3 years of related experience in document control and/or training coordination.
- Previous working experience in a GMP/GLP environment is required.
- Experience with a digital QMS such as Veeva, Title 21, or equivalent.
- Able to meet deadlines on short notice due to changes in patient status/enrollment
Preferred Qualifications:
- Knowledge in cell and gene therapy
- Working knowledge of FACT Common Standards for Cellular Therapy, 21 CFR 210 & 211, and ICH Guidelines
