Quality Specialist, Peptide API & Development

Quality Specialist

We are looking for a highly organized, detail-oriented Quality Specialist to support Quality operations at a peptide-focused API manufacturing and development site. This role will help execute and maintain core GMP quality systems needed to support peptide API manufacturing, laboratory activities, and an early-phase drug product development environment designed to feed future tech transfers into 503A and 503B operations. The ideal candidate is comfortable working in a startup setting, can manage documentation and follow-through with a high level of discipline, and is eager to help build a practical, inspection-ready Quality foundation from the ground up.

Core Skills & Traits

• 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.

You Will:

• 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.
• Assist with issuance, tracking, reconciliation, and archival of controlled documents such as SOPs, forms, logbooks, protocols, and reports.
• Support batch record review activities for peptide API manufacturing and related operations, escalating issues to Quality leadership as appropriate.
• Assist in tracking and coordinating deviations, investigations, CAPAs, change controls, and associated action items 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.
• Assist with 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.
• Help 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.

You Have:

• Bachelor's degree in Chemistry, Biology, Biochemistry, Pharmaceutical Sciences, or related field preferred.
• 25+ 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.

Working Environment

• Startup environment with evolving processes and priorities.
• 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.

Our Benefits (there are more but here are some highlights):

• 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