Quality Specialist, Peptide API & Development

About the role

We are seeking a Quality Specialist to support Quality operations at a peptide-focused API manufacturing and development site. The role involves executing and maintaining core GMP quality systems, including document control, training, deviations, CAPA, change control, and record management.

Responsibilities

• Support day-to-day execution of site Quality Systems, including document control, training, deviations, CAPA, change control, and record management.
• Review GMP records for completeness, accuracy, and compliance with approved procedures and Good Documentation Practices.
• Affirm batch record review activities for peptide API manufacturing and related operations, escalating issues to Quality leadership as appropriate.
• Assist with deviation, investigation, CAPA, change control, and associated action item tracking to closure.
• Support training administration, including assignment tracking, training matrix maintenance, and follow-up on overdue training.
• Participate in routine walkthroughs of manufacturing, laboratory, warehouse, and support areas to reinforce compliance and identify improvement opportunities.
• Support qualification, validation, and startup documentation activities, including protocol/report routing and document completeness checks.
• Affirm supplier quality, material status controls, and documentation associated with incoming materials, specifications, and quality records.
• Support inspection readiness activities, including preparation of records, document retrieval, and participation in internal and external audits.
• Maintain quality metrics, logs, and trackers to support trending, management review, and continuous improvement.
• Partner with Operations, Engineering, and Technical teams to ensure quality expectations are understood and implemented consistently.

Requirements

• Bachelor’s degree in Chemistry, Biology, Biochemistry, Pharmaceutical Sciences, or related field preferred.
• 2–5+ years of experience in Quality, manufacturing, laboratory, or document control roles in pharmaceutical, biotech, or other GMP-regulated environments.
• Experience with peptide API, sterile operations, laboratory controls, or startup/manufacturing support environments is a plus.
• Working knowledge of cGMP principles, Good Documentation Practices, and basic quality systems concepts.
• Strong organizational skills with the ability to manage multiple priorities and follow through on details.
• Experience using electronic quality systems, document management systems, or training systems is preferred.

Qualifications

• Detail-Oriented: Maintains accuracy and consistency in GMP records and documentation.
• Execution-Focused: Follows through on assignments and helps drive actions to closure.
• Quality Mindset: Understands the importance of compliance, traceability, and controlled execution.
• Collaborative: Works effectively across Quality, Operations, Engineering, and Technical teams.
• Adaptable: Comfortable supporting a growing site where systems and responsibilities are evolving.
• Proactive: Identifies gaps early, asks good questions, and brings solutions-oriented thinking.

Skills

• Detail-Oriented
• Execution-Focused
• Quality Mindset
• Collaborative
• Adaptable
• Proactive

Benefits

• Competitive salary & equity compensation for full-time roles
• Unlimited PTO, company holidays, and quarterly mental health days
• Comprehensive health benefits including medical, dental & vision, and parental leave
• Employee Stock Purchase Program (ESPP)
• 401k benefits with employer matching contribution
• Offsite team retreats

Pay

Competitive salary & equity compensation for full-time roles

Schedule

Frequent interaction with manufacturing, laboratory, and development teams. Regular onsite presence in GMP and support areas. May require flexibility in working hours to support startup, validation, and operational needs.