Quality Assurance Specialist - Torrance
About The Position
At PolyPeptide, quality is not a back-office function, it’s central to how we deliver life-changing products to patients worldwide. As a QA Compliance Specialist I, you will be a key contributor to maintaining and strengthening our GMP quality systems while gaining hands-on experience in a highly regulated pharmaceutical manufacturing environment. This role is ideal for someone early in their QA career who wants meaningful responsibility, exposure to cross-functional teams, and a clear path for growth within Quality Assurance. You’ll support and help maintain the quality systems that ensure our operations meet regulatory requirements, internal standards, and customer expectations.
Requirements
- Bachelor’s degree in a scientific or technical discipline (Chemistry, Biology, Pharmaceutical Sciences, or similar)
- 1–3 years of experience in Quality Assurance within a GMP-regulated pharmaceutical or biotechnology environment
- Solid understanding of cGMP principles and quality systems
- Familiarity with FDA and ICH regulatory expectations
- Strong attention to detail and organizational skills
- Clear, effective written and verbal communication
- Ability to manage multiple priorities in a fast-paced environment
- Curiosity, accountability, and a continuous-improvement mindset
Nice To Haves
- Experience with deviations, CAPAs, or document control is a plus
- Experience in peptide or oligonucleotide manufacturing is a plus, but not required.
Responsibilities
- Support core quality systems including deviations, CAPAs, and document control
- Assist with change controls, periodic reviews, document issuance, and reconciliation of records
- Monitor site quality systems and help prepare annual summary reports for:
- Environmental and water monitoring
- Equipment qualification and validation activities
- Preventive maintenance and trending programs
- Support investigations, root cause analyses, and OOS/OOT events, ensuring documentation is compliant, thorough, and well-reasoned
- Organize and archive records in accordance with retention policies and internal procedures
- Support training and onboarding activities across departments
- Maintain training records and ensure documentation is complete and audit-ready
- Partner with Manufacturing, Development, Project Management, Regulatory Affairs, and Corporate Quality teams
- Support internal and external audits, including preparation and follow-up activities
- Contribute to site-wide efforts to maintain compliance with cGMP, FDA, and ICH guidelines
- Perform additional duties as needed to support Quality and site operations
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Number of Employees
1,001-5,000 employees
