Drug Product QA Specialist — GMP Oversight & Release

Cytokinetics, Inc.; Radnor (Delaware County); Vor Ort; USD 134.000 - 156.000; Vollzeit

Benefits dieser Stelle

Stock options

RSUs

Health, dental, vision insurance

401k with employer match

Paid time off

Wellness stipends

Zusammenfassung

Cytokinetics, Inc. in Radnor, PA is seeking a QA Specialist for Drug Product to provide GMP oversight and review batch documentation across CMOs and CTLs, supporting QP functions and lifecycle management.

You will review batch records, deviations, CAPAs, change controls, and QMS records; collaborate with Regulatory Affairs and Manufacturing; ensure compliance with cGMPs and global guidance.

Qualifikationen

• Bachelor's degree in a scientific, engineering or technical discipline.
• Minimum of 5 years in biopharmaceutical/pharma QA with at least 3 years in QA.
• Experience supporting clinical and/or commercial manufacturing.
• Experience with GMP documentation review and batch disposition.

Aufgaben

• Provide GMP QA oversight for clinical and commercial manufacturing at CMOs.
• Review batch records and supporting docs for cGMP compliance.
• Review documentation to support batch disposition and release.
• Review and approve deviations, investigations, CAPAs, and change controls.
• Assess quality events for product impact and support risk-based decisions.
• Support technology transfers, process validation, and PPQ activities.
• Review GMP documentation including SOPs, MBRs, specifications, and reports.
• Participate in internal and supplier audits and regulatory inspections.
• Support Product Quality Reviews, APRs, and Quality Metrics reporting.

Kenntnisse

GMP QA experience

Documentation review

Cross-functional collaboration

Regulatory knowledge

Quality systems

Risk assessment

OOS/OOT investigations

Ausbildung

Bachelor's degree in science/engineering

Tools

eQMS (Veeva/TrackWise)

Jobbeschreibung

Cytokinetics, Inc. in Radnor, PA is seeking a QA Specialist for Drug Product to provide GMP oversight and review batch documentation across CMOs and CTLs, supporting QP functions and lifecycle management.

You will review batch records, deviations, CAPAs, change controls, and QMS records; collaborate with Regulatory Affairs and Manufacturing; ensure compliance with cGMPs and global guidance.