Education: Bachelor's degree or related field
Experience: 2+ years
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.
- 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.
- 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.
- 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.
- Startup environment with evolving processes and priorities.
- Frequent interaction with manufacturing, laboratory, and development teams.
- May require flexibility in working hours to support startup, validation, and operational needs.
- 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
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