Quality Specialist, Peptide API & Development

About the role

The Quality Specialist will own the execution and maintenance of core GMP quality systems for a peptide-focused API manufacturing and development site. This role is responsible for supporting day-to-day quality operations that ensure compliance and readiness for inspections. You will manage documentation control, batch record reviews, and deviations to maintain strict traceability and controlled execution. The position requires a proactive mindset to identify gaps early and drive solutions-oriented thinking across cross-functional teams. You will partner closely with Operations, Engineering, and Technical teams to align on quality expectations and implementation. This role is critical in building a practical, inspection-ready Quality foundation from the ground up for future scale-up. The work involves supporting validation, qualification, and startup activities to ensure all records are complete and routed appropriately. You will contribute directly to the reliability and integrity of manufacturing data used in regulatory and internal reviews.

Key facts

What you'll do

• 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.

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.
• 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.

Nice to have

• 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.

Practical notes

• Full-time engagement in Menlo Park, California.
• Startup environment with evolving processes and priorities.
• Frequent interaction with manufacturing, laboratory, and development teams.
• Regular onsite presence in GMP and support areas.
• Willingness to support quality metrics, logs, and trackers for trending and management review.
• Participation in internal and external audits as part of inspection readiness activities.
• Collaboration with cross-functional teams including Operations, Engineering, and Technical functions.
• Adherence to cGMP principles, Good Documentation Practices, and controlled execution of procedures.
• Supplier quality and material status controls are part of routine responsibilities.
• Qualifications, validation, and startup documentation support are included in day-to-day tasks.
• Training administration includes assignment tracking and maintenance of training matrices.
• The role contributes to building an inspection-ready quality foundation for future operations.
• Compliance during walkthroughs of manufacturing, laboratory, warehouse, and support areas is required.
• The position supports early-phase drug product development environments that interface with future 503A and 503B operations.
• Reconciliation of controlled documents ensures traceability and completeness for regulatory readiness.
• The specialist will escalate batch record issues to Quality leadership to maintain data integrity.
• Action items related to deviations and CAPAs are tracked to closure with appropriate documentation.
• The role requires flexibility within a growing site where systems and responsibilities continue to evolve.
• Management review and trending are supported through quality metrics, logs, and trackers.
• The position is critical in ensuring quality expectations are consistently understood across teams.
• Documentation issuance, tracking, and archival are handled with attention to regulatory standards.
• The specialist will participate in routine audits to ensure ongoing compliance and readiness.
• GMP records are reviewed for completeness, accuracy, and adherence to approved procedures.
• Controlled documents are managed through issuance, tracking, reconciliation, and archival processes.
• Supplier quality documentation and material specifications are maintained as part of routine activities.
• Qualification and validation documentation are routed and checked for completeness.
• The role supports the integrity of data used in manufacturing and regulatory submissions.
• Training administration ensures overdue training is tracked and addressed promptly.
• The position operates within a startup framework that values inspection-ready quality systems.
• Collaboration ensures quality expectations are implemented consistently across all teams.
• The specialist helps maintain quality metrics that support continuous improvement initiatives.
• Documentation control processes are executed with attention to detail and compliance.
• The role requires strong organizational skills to manage multiple priorities effectively.
• The position contributes to the overall mission of delivering accessible and personalized care through better health outcomes.
• The specialist supports the foundational systems needed for future scale-up into 503A and 503B operations.
• Execution-focused tasks ensure actions are driven to closure with proper documentation.
• The role maintains traceability through accurate and consistent GMP records.
• The specialist is expected to ask good questions and provide solutions-oriented thinking.
• The position requires adaptability to evolving systems and responsibilities in a growing site.
• Proactive gap identification supports ongoing compliance and quality system integrity.
• The role participates in internal and external audit preparations and activities.
• Quality metrics, logs, and trackers are maintained to support management review and trending.
• The specialist works closely with cross-functional teams to ensure alignment on quality standards.
• The position supports batch record review and escalation to Quality leadership when necessary.
• Documentation reconciliation ensures completeness and supports regulatory readiness.
• The role contributes to a practical, inspection-ready Quality foundation from the ground up.
• The specialist supports early-phase drug product development in alignment with future operational needs.
• All activities are conducted with attention to cGMP principles and Good Documentation Practices.
• The position requires frequent onsite presence in GMP and support areas.
• The role supports quality expectations across manufacturing, laboratory, warehouse, and development teams.
• The specialist helps maintain supplier quality controls and material status documentation.
• Qualification and validation activities are supported with thorough documentation checks.
• The role ensures that protocols and reports are routed and completed appropriately.
• Training matrix maintenance is part of the routine responsibilities.
• The position supports the stability and reliability of quality systems in a startup environment.
• The specialist contributes to continuous improvement through trending and management review processes.
• Documentation control includes issuance, tracking, and archival of all controlled quality documents.
• The role ensures that deviations and investigations are tracked and resolved.
• The position supports change control processes to maintain system integrity.
• The specialist helps prepare records for inspection readiness and regulatory audits.
• All responsibilities are executed with a focus on compliance, accuracy, and detailed follow-through.
• The role supports the overall mission of the company to normalize health challenges and deliver personalized care.
• The specialist operates within a quality framework that values transparency, traceability, and proactive problem-solving.
• The position requires strong organizational skills to manage documentation and action items effectively.
• The role contributes to building sustainable quality systems for future growth and scale-up.
• The specialist supports batch release activities and ensures data integrity in manufacturing records.
• All tasks are completed with awareness of regulatory standards and customer-first care delivery.
• The position requires collaboration across Quality, Operations, Engineering, and Technical teams.
• The specialist helps maintain quality metrics that inform leadership reviews and continuous improvement.
• Documentation accuracy and compliance are maintained through routine reviews and checks.
• The role supports the execution of validation protocols and report routing.
• The specialist participates in internal audits to ensure ongoing compliance.
• The position maintains training records and ensures overdue training is addressed.
• The role contributes to supplier quality documentation and incoming material controls.
• The specialist supports the integrity of laboratory controls and quality records.
• All activities are aligned with cGMP principles and Good Documentation Practices.
• The position requires adaptability and a proactive approach in a evolving startup environment.
• The specialist helps maintain quality systems that are inspection-ready and compliant.
• The role supports early-phase development and future tech transfers into commercial operations.
• All responsibilities are designed to support the mission of better hea