Senior QA Specialist, Drug Substance & CMO Oversight

Cytokinetics Incorporated; South San Francisco (CA); Hybride; USD 140 000 - 164 000; Plein temps

Résumé du poste

Cytokinetics Incorporated is seeking a QA Specialist for Drug Substance to provide QA oversight of clinical and commercial manufacturing at CMOs, review batch records, and support release and lifecycle management activities. The role involves assuring cGMP compliance and timely investigations and CAPAs to maintain product quality.

You will collaborate with Regulatory Affairs, Technical Operations, Supply Chain and Manufacturing teams, perform QA reviews, maintain documentation in eQMS, and help

Qualifications

• Bachelor's degree in a scientific, engineering or technical discipline.
• Minimum 5 years in biopharmaceutical/pharmaceutical QA with 3+ years in GMP QA.
• Experience reviewing GMP batch documentation and batch disposition.
• Experience with CMOs/externally manufactured operations.
• Strong knowledge of US FDA, EU EMA and ICH cGMP guidance.

Responsabilités

• Provide GMP QA oversight for clinical and commercial manufacturing and distribution at CMOs.
• Perform quality reviews of batch records and supporting documentation to ensure cGMP compliance.
• Review manufacturing/testing documentation to support batch disposition and release.
• Approve deviations, investigations, CAPAs, and change controls and ensure root cause analysis.
• Assess quality events for potential product impact and support risk-based decisions.
• Support technology transfers, process validation, and PPQ activities.
• Review SOPs, MBRS, specifications, protocols, and reports.
• Participate on cross-functional teams supporting programs and audits.

Connaissances

QA oversight

Batch documentation review

cGMP compliance

Deviations & CAPAs

Regulatory inspections

Cross-functional collaboration

eQMS familiarity

CMC submissions support

Formation

Bachelor's degree in science/engineering/technical

Outils

Veeva Quality

TrackWise

eQMS systems

Description du poste

Cytokinetics Incorporated is seeking a QA Specialist for Drug Substance to provide QA oversight of clinical and commercial manufacturing at CMOs, review batch records, and support release and lifecycle management activities. The role involves assuring cGMP compliance and timely investigations and CAPAs to maintain product quality.

You will collaborate with Regulatory Affairs, Technical Operations, Supply Chain and Manufacturing teams, perform QA reviews, maintain documentation in eQMS, and help