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

• Provides QA support during production operations, including in-process checks and line clearance

• Collaborates with Manufacturing, QC, and other cross-functional departments to resolve quality issues and improve processes

• Ideal for candidates with strong GMP experience who can manage multiple quality activities with limited supervision

Quality Assurance Specialist III

• Senior-level QA specialist and experienced quality resource

• Performs complex batch record review, documentation review, and quality system support with a high degree of independence

• Supports material, intermediate, finished goods, and API release activities in coordination with QA leadership

• Provides advanced support for investigations, deviations, CAPAs, non-conformances, and change controls

• Participates in audit preparation, inspection readiness, quality system improvements, and cross-site quality initiatives

• Partners with Manufacturing, QC, Regulatory Affairs, Project Management, Engineering, and Corporate Quality on customer projects and regulatory activities

• Ideal for candidates with significant GMP experience who can help drive compliance, quality culture, and continuous improvement

Qualifications

• 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

• Experience in peptide or oligonucleotide manufacturing is a plus

Skills and Competencies

Successful candidates will bring:

• 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

What Makes You Successful in This Role

You are detail-oriented, organized, and comfortable working in a regulated environment where accuracy matters. You understand the importance of documentation, compliance, and timely communication.

You are able to partner with cross-functional teams, identify potential quality concerns, and support solutions that protect product quality and customer commitments. You take ownership of your work, communicate clearly, and help maintain a strong quality culture.

Why Join PolyPeptide

At PolyPeptide Laboratories, you will do meaningful quality work that directly supports pharmaceutical therapies and customer programs. We offer a collaborative, compliance-focused environment where your attention to detail, documentation expertise, and quality mindset help ensure products are manufactured and released the right way.

As part of the Quality Assurance team, you will help protect product quality, support regulatory compliance, and contribute to continuous improvement across the site. Your work here will not only support your career growth; it will help deliver medicines that make a difference.

If you are looking for a role where your QA experience, attention to detail, and commitment to compliance can make a direct impact, we encourage you to apply.

Salary :
Quality Assurance Specialist I : $55k-$70k
Quality Assurance Specialist II : $65k-$80k
Quality Assurance Specialist III : $75k-$95k

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.