Quality Assurance Specialist

Location: Torrance, CA | Employment Type: Full-Time

Why This Role Matters

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.

What You’ll Do

You’ll support and help maintain the quality systems that ensure our operations meet regulatory requirements, internal standards, and customer expectations.

Quality Systems & Compliance

• 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

Documentation & Training

• 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

Collaboration & Audits

• 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

What We’re Looking For

Education

• Bachelor’s degree in a scientific or technical discipline (Chemistry, Biology, Pharmaceutical Sciences, or similar)

Experience

• 1–3 years of experience in Quality Assurance within a GMP-regulated pharmaceutical or biotechnology environment

Skills That Will Help You Succeed

• Solid 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, effective written and verbal communication

• Ability to manage multiple priorities in a fast-paced environment

• Curiosity, accountability, and a continuous-improvement mindset

Experience in peptide or oligonucleotide manufacturing is a plus, but not required.

How You’ll Be Measured

• Timely and accurate support of deviations, CAPAs, and investigations

• High-quality, compliant documentation

• Audit readiness and adherence to cGMP standards

• Effective collaboration across departments

Work Environment

This role may be based in an office, laboratory, or GMP manufacturing setting. Depending on assignments, you may:

• Sit or stand for extended periods

• Move between work areas

• Lift up to 25 pounds occasionally

• Work with electronic systems, documentation, and laboratory or production environments requiring PPE

• Occasionally work evenings or weekends to support operations

• Reasonable accommodations will be provided as needed.

About PolyPeptide

PolyPeptide is a global leader in peptide-based active pharmaceutical ingredients, partnering with innovators worldwide to deliver high-quality, reliable solutions that support the development of life-changing therapies. Our teams are driven by science, collaboration, and a shared commitment to excellence in everything we do.

At PolyPeptide, quality is foundational, not just a requirement, but a mindset embedded across our operations. We offer a collaborative environment where employees are encouraged to learn, grow, and make a meaningful impact.

If you’re ready to build your Quality Assurance career while contributing to products that matter, we’d love to hear from you.

Salary: $34-$38/hr

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.