QA Analyst, GMP Doc Control (CVPF)(Center for Cellular Immunotherapy)

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Posted Job Title

QA Analyst, GMP Doc Control (CVPF)(Center for Cellular Immunotherapy)

Job Profile Title

Research Coordinator

Job Description Summary

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.

Job Description

Job 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.
• Assi