Quality Assurance Specialist II
About The Position
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. Your attention to detail and regulatory expertise will help uphold the highest standards of safety, consistency, and customer trust. What You'll Do 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. What We're Looking For Bachelor's degree in a scientific discipline (Chemistry, Biology, Pharmaceutical Sciences, or related field). 3-5 years of quality assurance experience in a GMP-regulated pharmaceutical, biotech, or CDMO environment. Strong understanding of FDA, ICH, and EU regulatory requirements. Experience with batch record review, investigations, and CAPA systems. Excellent communication, organization, and problem-solving skills. Proficiency with Microsoft Office and experience using eQMS systems preferred. Why PolyPeptide? 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. Your work will directly impact global health and help ensure the highest standards in pharmaceutical manufacturing. Build your career in quality. Make every detail count.
Requirements
- Bachelor's degree in a scientific discipline (Chemistry, Biology, Pharmaceutical Sciences, or related field).
- 3-5 years of quality assurance experience in a GMP-regulated pharmaceutical, biotech, or CDMO environment.
- Strong understanding of FDA, ICH, and EU regulatory requirements.
- Experience with batch record review, investigations, and CAPA systems.
- Excellent communication, organization, and problem-solving skills.
Nice To Haves
- Proficiency with Microsoft Office and experience using eQMS systems preferred.
Responsibilities
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Industry
Chemical Manufacturing
Number of Employees
1,001-5,000 employees
