Senior QA Specialist – GMP, Investigations & Product Release

Kindeva; Bridgeton (MO); Vor Ort; USD 65.000 - 90.000; Vollzeit

Zusammenfassung

Kindeva is seeking a QA Specialist II to provide advanced quality oversight across production and testing activities. You will review batch documentation, lead investigations, and participate in change control to ensure timely product release.

Ideal candidates will have experience with cGMPs, batch record review, deviation investigations, and a collaborative approach to drive quality improvements within a manufacturing environment.

Qualifikationen

• Bachelor’s degree or 3+ years in pharma with batch record review experience.
• Experience with cGMPs (USFDA, Health Canada, PIC/S).
• Experience in investigations and CAPA.
• Ability to work under tight timelines while maintaining quality.

Aufgaben

• Evaluate and approve batch documentation and determine product disposition.
• Provide quality oversight for manufacturing and testing activities.
• Identify and resolve non-conformances and recommend corrective actions.
• Review batch records and SOPs for regulatory alignment.
• Participate in internal GMP audits and customer/regulatory audits.
• Perform ERP transactions ensuring accurate documentation.

Kenntnisse

Batch record review

GMP knowledge

Investigations

Quality oversight

Cross-functional collaboration

Ausbildung

Bachelor's degree in Chemistry, Biology, Microbiology, Pharmacy, Engineering, or other science-related discipline

Jobbeschreibung

Kindeva is seeking a QA Specialist II to provide advanced quality oversight across production and testing activities. You will review batch documentation, lead investigations, and participate in change control to ensure timely product release.

Ideal candidates will have experience with cGMPs, batch record review, deviation investigations, and a collaborative approach to drive quality improvements within a manufacturing environment.