Sr. Quality Assurance Specialist - San Diego
About The Position
Join a team dedicated to quality, innovation, and impact. PolyPeptide is a global leader in peptide manufacturing, supporting some of the most advanced therapies in the pharmaceutical and biotechnology industries. We are seeking a Senior Quality Assurance Specialist who is passionate about quality, compliance, and continuous improvement. In this role, you will play a critical part in ensuring that clinical and commercial products meet the highest regulatory and quality standards while contributing directly to PolyPeptide’s commitment to delivering exceptional quality and on-time delivery to our customers. This is an excellent opportunity for an experienced QA professional to work in a collaborative, science-driven environment and contribute to products that support life-changing therapies worldwide. The Senior Quality Assurance Specialist ensures compliance with regulatory standards and internal procedures by overseeing key quality activities associated with cGMP manufacturing and testing. This role supports product release for clinical and commercial products, manages quality documentation, and participates in investigations, audits, and process improvements across the organization. Working closely with cross-functional teams including Manufacturing, Quality Control, Regulatory Affairs, and Corporate Quality, this position helps maintain PolyPeptide’s strong regulatory compliance record and commitment to operational excellence.
Requirements
- Bachelor’s degree in a scientific discipline such as Chemistry, Biology, or Pharmaceutical Sciences
- 5–7 years of Quality Assurance experience in a pharmaceutical, biotechnology, or CDMO environment
- Strong understanding of FDA, EMA, ICH, and cGMP regulations
- Ability to make independent compliance decisions based on regulatory knowledge, risk evaluation, and available data
- Experience reviewing technical documentation and manufacturing records
- Strong analytical thinking and problem-solving skills
- Excellent written and verbal communication
- Ability to manage priorities and collaborate across departments
- GMP compliance and regulatory knowledge
- Quality documentation and batch record review
- Attention to detail and accuracy
- Cross-functional communication and collaboration
- Deviation investigation and problem resolution
Nice To Haves
- Lean Six Sigma certification
- Experience with Active Pharmaceutical Ingredients (APIs) preferred
- Experience with peptides or oligonucleotides highly desirable
Responsibilities
- Participate in core QA activities including deviation investigations, batch record review, annual product review, QC data review, and generation of Certificates of Analysis (CoA) for clinical and commercial product release.
- Update and maintain Standard Operating Procedures (SOPs) and Material Review Reports.
- Coordinate and interact with contract testing laboratories.
- Provide backup support for Quality Assurance Specialist (Compliance) activities including: Supplier audits Change control CAPA management Complaint handling Document control systems cGMP training support
- Provide backup support, as delegated, for lot release authority.
- Ensure site adherence to Quality System requirements, cGMP standards, and ICH guidelines.
- Support the annual review and continuous improvement of the Quality System, including operational efficiency improvements and regulatory updates.
- Collaborate with Regulatory Affairs, Manufacturing, Development, Marketing, and Corporate Quality on customer projects, regulatory submissions, and global quality standard harmonization.
- Contribute to maintaining PolyPeptide’s strong compliance record with FDA and other regulatory agencies.
- Perform additional responsibilities as assigned.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
