Senior GMP QA Specialist: Drug Product & CMO Oversight

Cytokinetics Incorporated; Radnor (Delaware County); On-site; USD 134,000 - 156,000; Full time

Benefits offered by this job

Stock options equity

Health, dental, vision insurance

401k retirement with match

Learning and wellness stipends

Paid time off

Job summary

Cytokinetics Incorporated in Radnor, PA is seeking a QA Specialist for Drug Product to provide GMP quality assurance oversight across manufacturing, packaging, labeling and distribution activities performed by CMOs and CTLs. You will review clinical and commercial batch records, deviations, investigations and CAPAs, support technology transfers and process validation, and ensure timely product disposition.

The role collaborates with Regulatory Affairs, Technical Operations and Supply Chain to

Qualifications

• Bachelor's degree in a scientific, engineering or technical discipline is required.
• Minimum of 5 years in biopharma/pharma with at least 3 years in GMP QA.
• Experience supporting clinical and/or commercial pharmaceutical manufacturing.
• Experience with oral solid dose manufacturing and packaging.
• Working knowledge of US FDA/EMA/ICH cGMP regulations.

Responsibilities

• Provide GMP QA oversight for clinical and commercial manufacturing, packaging, labeling and distribution activities at CMOs/CTLs.
• Review GMP batch documentation to ensure compliance with cGMP and regulatory filings.
• Review and approve deviations, investigations, CAPAs, change controls and QMS records.
• Support technology transfers, process validation and PPQ activities.
• Participate in internal/audits, supplier audits and regulatory inspections.

Skills

GMP quality assurance

Document review

Contract manufacturing oversight

Regulatory compliance

Audits & inspections

Quality systems

Cross-functional collaboration

Education

Bachelor's degree in science/engineering

Tools

eQMS (Veeva/TrackWise)

Job description

Cytokinetics Incorporated in Radnor, PA is seeking a QA Specialist for Drug Product to provide GMP quality assurance oversight across manufacturing, packaging, labeling and distribution activities performed by CMOs and CTLs. You will review clinical and commercial batch records, deviations, investigations and CAPAs, support technology transfers and process validation, and ensure timely product disposition.

The role collaborates with Regulatory Affairs, Technical Operations and Supply Chain to