Quality Assurance Specialist - San Diego
About The Position
PolyPeptide is seeking a Quality Assurance Specialist I, II, or III to support quality assurance activities in a cGMP-regulated pharmaceutical manufacturing environment. These roles are critical to ensuring that manufacturing operations, documentation, quality systems, and product release activities comply with regulatory requirements, internal policies, and customer expectations. Whether you are building your QA career or are an experienced quality professional ready to take on more complex responsibilities, we offer a clear growth path, cross-functional exposure, and the opportunity to support high-quality peptide and pharmaceutical manufacturing. As a Quality Assurance Specialist, you will support day-to-day QA operations across manufacturing, quality systems, documentation, batch review, material release, production support, and inspection readiness. You will work closely with Manufacturing, Quality Control, Engineering, Maintenance, Regulatory Affairs, Project Management, and Quality leadership to help ensure compliance, accuracy, and on-time delivery.
Requirements
- Quality Assurance Specialist I: 2 to 4 years of QA experience in a GMP-regulated pharmaceutical, biotech, CDMO, or related environment
- Quality Assurance Specialist II: 3 to 5 years of QA experience in pharmaceutical, biotech, CDMO, or GMP-regulated manufacturing
- Quality Assurance Specialist III: 5 or more years of QA experience in pharmaceutical manufacturing, quality assurance, or another regulated environment
- Strong understanding of cGMP compliance and regulatory expectations
- Strong documentation review skills and commitment to accuracy
- Good Documentation Practices knowledge
- Strong attention to detail and organizational skills
- Effective written and verbal communication skills
- Ability to work cross-functionally with Manufacturing, QC, Engineering, Maintenance, Regulatory Affairs, and Quality teams
- Strong problem-solving and critical thinking skills
- Ability to identify, communicate, and escalate quality concerns appropriately
- Ability to work independently and collaboratively in a fast-paced regulated environment
- Commitment to quality, compliance, and continuous improvement
- Detail-oriented, organized, and comfortable working in a regulated environment where accuracy matters.
- Understand the importance of documentation, compliance, and timely communication.
- Able to partner with cross-functional teams, identify potential quality concerns, and support solutions that protect product quality and customer commitments.
- Take ownership of your work, communicate clearly, and help maintain a strong quality culture.
Nice To Haves
- Experience in peptide or oligonucleotide manufacturing is a plus
Responsibilities
- Review batch production records, laboratory results, and associated documentation for completeness, accuracy, and cGMP compliance
- Support batch disposition activities and API batch release in coordination with QA leadership
- Review and release raw materials, intermediates, and finished goods based on internal quality and QC testing requirements
- Perform document control activities, including logbook, notebook, form, SOP, and quality record review
- Support line clearance, in-process checks, API label creation, and production floor QA activities
- Maintain regular communication with Operations team leads to review batch records and resolve minor documentation or process events
- Escalate major or critical observations to QA management for assessment
- Support Engineering, Maintenance, and Production documentation needs, including review of PMs, calibration records, function tests, work orders, and related documents
- Assist with investigations and documentation related to deviations, non-conformances, CAPAs, complaints, and change controls
- Support supplier audits, internal audits, inspection readiness, and regulatory inspection preparation
- Ensure Good Documentation Practices, cGMP, ICH, FDA, EU, and applicable regulatory guidelines are followed
- Maintain QA records in paper and electronic systems, ensuring accuracy and traceability
- Contribute to SOP, protocol, form, and quality documentation development and review
- Participate in annual product reviews and quality system improvement activities
- Partner with cross-functional teams on customer projects, regulatory submissions, harmonization efforts, and continuous improvement initiatives
Benefits
- clear growth path
- cross-functional exposure
- opportunity to support high-quality peptide and pharmaceutical manufacturing
- collaborative, compliance-focused environment
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
No Education Listed
