Poseida Therapeutics, Inc. is seeking an outstanding candidate to join our Quality group at our La Jolla, San Diego, CA location. The Quality Assurance Associate will provide Quality support for the manufacture and testing of non-clinical and clinical products. This position will be responsible for reviewing batch records and associated data for product release, ensuring compliance with specifications and evaluation of deviations on product quality, and works with process owners to resolve documentation issues. The QA Associate will be accountable for assuring compliance with Quality systems, oversight at the project level and generation of interface with our Research and Development teams as well as with outside Contract Manufacturing Organizations. The ideal candidate will have experience creating, maintaining, and ensuring completeness and accuracy of information. The candidate will have good oral and written communication skills, and will be highly detail oriented.
Job Duties and Responsibilities:
- Reviews production batch records and associated data for product release. Determines if records are within range of cGMP expectations. Reviews data obtained for compliance specifications and report abnormalities.
- Evaluates the impact of deviations and adverse events to product quality.
- Creates, revises, and reviews SOPs including compliance documentation initiation, revisions, and deletions.
- Ensures completeness and accuracy of information contained in all documents, document files, databases, and documentation systems.
- Performs logbook documentation audits for cGMP regulated logs and SOPs.
- Creates cGMP labels, and reviews and reconciles cGMP label generation.
- Align daily actions with department goals and company culture.
Preferred Experience and Skills:
- Bachelor’s degree strongly preferred in a Life Sciences discipline or equivalent.
- 3-5 years of relevant experience in documentation review, QA or equivalent exposure.
- Working knowledge of cGMP regulations 21 CFR Part 11, 210, 211, 600 and good documentation practices.
- Experience in investigations writing and review preferred.
- Knowledge of Fill Finish and Biologics production environments strongly preferred.
- Detail oriented with strong written and verbal communication skills.
- Ability to work independently, within prescribed guidelines, or as a team member.
Poseida Therapeutics is translating best-in-class gene editing technologies into lifesaving treatments. The company is developing CAR T-cell immunotherapies for multiple myeloma and other cancer types, as well as gene therapies for orphan diseases. Poseida has assembled a suite of industry-leading gene editing technologies, including the piggyBac™ DNA Modification System, XTN™ TALEN and NextGEN™ CRISPR site-specific nucleases, and Footprint-Free™ Gene Editing (FFGE). For more information, visit www.poseida.com.