Quality Assurance Specialist Role at PolyPeptide Group USA
PolyPeptide Group is hiring a Quality Assurance Specialist in Torrance, CA. This quality assurance job offers hands-on experience in GMP compliance, exposure to cross-functional teams, and a clear growth path for early-career professionals in pharmaceutical manufacturing. Join our team and make an impact in delivering life-changing therapies.
Job Details:
- Support and maintain 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 prepare annual reports on environmental/water monitoring, equipment validation, and preventive maintenance
- Support investigations, root cause analyses, and OOS/OOT events with thorough documentation
- Organize and archive records according to retention policies and internal procedures
- Maintain training records and support departmental onboarding activities
- Collaborate with Manufacturing, Development, Project Management, Regulatory Affairs, and Corporate Quality teams
- Support internal and external audits, ensuring compliance with cGMP, FDA, and ICH guidelines
- Perform additional duties to support Quality and site operations
About the Company:
PolyPeptide Group is a global leader in peptide-based active pharmaceutical ingredients (APIs), delivering high-quality solutions to pharma and biotech innovators. Founded in 1996, the company operates a worldwide manufacturing network across Europe, the U.S., and India. At PolyPeptide, quality assurance is not just a requirement but a mindset embedded in all operations, fostering collaboration, innovation, and continuous growth. Explore more quality assurance job offers.
Educational Requirements:
Bachelor’s degree in a scientific or technical discipline (Biology, Pharmaceutical Sciences, or similar)
Key Responsibilities of Quality Assurance Specialist Role:
- Timely and accurate support of deviations, CAPAs, and investigations
- Ensure high-quality, compliant documentation
- Maintain audit readiness and adherence to cGMP standards
- Collaborate effectively with cross-functional teams
- Contribute to continuous improvement initiatives in quality systems
Skills Required for Quality Assurance Specialist Role:
- Strong understanding of cGMP principles and quality systems
- Familiarity with FDA and ICH regulatory expectations
- Experience with deviations, CAPAs, or document control is a plus
- Strong attention to detail and organizational skills
- Clear written and verbal communication
- Ability to manage multiple priorities in a fast-paced environment
- Curiosity, accountability, and continuous improvement mindset
- Experience in peptide or oligonucleotide manufacturing is a plus
Benefits of the of Quality Assurance Specialist Role:
- Paid Holidays (13)
- Paid Vacation and Sick Leave
- Birthday Off
- Tuition Reimbursement Program
- Basic Life Policy & AD&D
- 401K (6% Matching)
- Health Insurance (Medical, Dental, Vision)
- Student Debt Reduction Program
- Fresh Fruit Program
