Quality Assurance Specialist II
PolyPeptide USTorrance, California, United States
Posted November 3, 2025
66000 - 84000 USD year
Full Time
About the Company
Join a company where quality meets purpose. At PolyPeptide, you’ll be part of a collaborative, science-driven team that values integrity, innovation, and excellence.
Job Description
At PolyPeptide, quality is at the core of everything we do. As a Quality Assurance Specialist II, you’ll ensure compliance with cGMP regulations and internal quality systems that support the manufacturing of peptide and oligonucleotide products.
Requirements
- Review batch records, laboratory data, and related documentation for cGMP compliance and completeness.
- Support release activities for raw materials, intermediates, and finished products.
- Assist in the investigation and documentation of deviations, non-conformances, CAPAs, and change controls.
- Participate in audits, inspection readiness, and documentation preparation for regulatory inspections.
- Ensure adherence to Good Documentation Practices (GDP) across all QA activities.
- Collaborate cross-functionally with Manufacturing, QC, and Engineering to resolve quality issues and drive continuous improvement.
- Maintain and organize QA records in both paper and electronic systems.
- Contribute to the development and review of SOPs, protocols, and other controlled documents.
