Quality System Specialist
Listed on 2026-09-10
-
Quality Assurance - QA/QC
QA Specialist - Analyst/Manager, Quality Control - QC Analysts/Managers
Help Ensure Quality in Life-Saving Biopharmaceuticals
Are you passionate about Quality Systems
, CAPAs, deviations, GMP compliance, and documentation excellence? We’re looking for a Senior Specialist, Quality Systems to join a growing biopharmaceutical team supporting innovative biologic therapies.
If you thrive in a fast-paced quality environment and enjoy working with deviation investigations, CAPAs, quality documentation, and inspection readiness
, this could be your next opportunity.
- Review, edit, and approve deviation reports, calibration exceptions, OOS, and OOL investigations
- Support CAPA authoring, review, and approval activities
- Prepare and review SOPs, forms, batch production records, and controlled documents
- Participate in the generation and revision of quality systems and project documentation
- Support development, validation, and stability documentation activities
- Collaborate with cross-functional teams to resolve quality system issues and discrepancies
- Represent Quality on multidisciplinary project teams
- Provide support to internal and external customers on Quality topics
- Maintain inspection readiness and support audit preparation activities
- Support continuous improvement initiatives and Quality Management System activities
B.A. or B.S. degree (preferably in a Life Sciences field)
Minimum 4–5 years of experience in the biopharmaceutical industry (preferably with biologics)
Hands-on experience or exposure with
:
- Quality Systems
- OOS Investigations
- Quality Documentation
- Quality Management Systems (QMS)
- Experience with biologics preferred
- Experience using Quality Management Systems and electronic document management systems
- Strong technical writing and editing skills
$42.69 – $53.36 per hour (depending on experience and qualifications)
Health, Dental, and Vision Insurance
401(k) Matching
Paid Time Off
Please Note- On-site in Tustin, CA
- Overtime and weekend availability may be required
- Applicants must already be authorized to work in the U.S.
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