Quality Assurance Specialist - San Diego

Quality Assurance Specialist Location: San Diego, CA | Employment Type: Full-Time Help ensure quality, compliance, and product readiness in a GMP environment 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. What You’ll Do, All Levels 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. Core 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 Level-Based Scope & Growth Quality Assurance Specialist I Early to mid-level QA role focused on supporting routine quality assurance activities Performs assigned tasks with guidance from QA leadership or senior QA team members Supports batch record review, document control, line clearance, API label creation, logbook review, notebook review, SOP updates, and material review reports Builds technical knowledge in cGMP compliance, Good Documentation Practices, quality systems, and regulated production support Ideal for candidates with foundational QA experience who are ready to grow in a GMP pharmaceutical manufacturing environment Quality Assurance Specialist II Experienced QA individual contributor with increasing independence and broader quality system responsibility Reviews batch production records, laboratory results, and quality documentation for completeness and compliance Supports release activities for raw materials, intermediates, and finished goods Assists with deviations, CAPAs, non-conformances, change controls, audits, and inspection readiness