QA Specialist I, GMP Gene Therapy Manufacturing
Overview
QA Specialist I owns document control and raw material release for a biopharmaceutical CDMO manufacturing gene therapies at clinical and commercial scale. You will ensure cGMP compliance across viral vector and plasmid production, reporting to the QA Manager and partnering with manufacturing operations. This role anchors the quality system for a company founded by gene therapy patients, with work directly impacting life-saving treatments. You will drive document control, internal audits, and metrics that keep the Quality Management System audit-ready for FDA and FACT standards.
What You'll Do8
- 1Coordinate the timely revision, review, approval, and management of GMP documents, including registering controlled documents and monitoring review cycles.
- 2Perform essential Document Control functions: issue production documents, scan, file, and archive GMP records to support manufacturing efficiency.
- 3Review and compare manufacturer's CofA and relevant documents to release raw materials for production use.
- 4Track and trend quarterly and annual metrics for QA staff and manufacturing management, mining production records to support timely product release.
- 5Assist the QA Manager with client audits by prepping documents, updating SOP binders, and executing internal audits.
- 6Act as liaison between QA and other departments to facilitate documentation revisions, implement Change Controls or CAPAs, and identify potential quality issues.
- 7Report deviations to procedures, specifications, or systems with data and corrective measures, maintaining compliance with FACT and regulatory requirements.
- 8Operate within the Quality Management System for phase appropriate material in the CMF, ensuring all activities are documented per SOPs
Requirements7
- 1Relevant four-year degree, with background in life sciences, biotechnology, or gene therapy industries preferred.
- 2No minimum experience required; prior experience with cGMP, GLP, or FDA guidelines preferred.
- 3Experience in a highly regulated field preferred, with attention to detail and ability to handle confidential information.
- 4Excellent communication, organization, and project management skills to manage multiple projects and adjust to changing priorities.
- 5Literate in Microsoft Office (PowerPoint, Excel, Word); familiarity with eQMS is a plus.
- 6Ability to work independently and collaboratively in a diverse, inclusive environment with a client-focused mindset.
- 7Demonstrate high integrity, positive attitude, and discretion in all job functions.
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