QA/QMS Senior: Deviations & Investigations Lead

Nivagen Pharmaceuticals; Sacramento (CA); Vor Ort; USD 110.000 - 140.000; Vollzeit

Benefits dieser Stelle

Yearly bonus

Medical coverage

Dental coverage

Vision coverage

Paid time off

Zusammenfassung

Nivagen Pharmaceuticals is seeking a QA/QMS Senior Specialist to lead deviations and investigations for sterile GMP manufacturing. You will own the lifecycle from initiation to closure, perform root cause analyses, and ensure FDA/cGMP compliance while coordinating across QA, QC, Engineering, and Validation teams.

The role requires strong investigative skills, technical writing ability, and experience with TrackWise or similar QMS systems, aiding inspection readiness and process improvements.

Qualifikationen

• Bachelor’s degree in Life Sciences, Chemistry, Pharmacy, Microbiology, Engineering, or related field.
• 7–10 years in QA with deviation investigations in sterile pharmaceutical manufacturing.
• Experience with root cause analysis tools (Ishikawa, 5-Why, FMEA, fault tree).
• Proficiency with TrackWise, Veeva QMS or similar electronic quality systems.

Aufgaben

• Own the deviation lifecycle from initiation through investigation, root cause analysis, CAPA identification, and closure.
• Serve as primary contact for deviation activities across Manufacturing, Quality Control, Engineering, and Validation.
• Prepare investigation narratives, IQAs, and final deviation reports in TrackWise.
• Classify deviations by severity and assess impact on quality, safety, and regulatory compliance.
• Coordinate batch disposition with QA batch release and QC labs.
• Monitor deviation KPIs and report trends for management review.

Kenntnisse

Root cause analysis

FMEA

Ishikawa

5-Why

Fault tree analysis

QMS knowledge

Technical writing

FDA/cGMP familiarity

Ausbildung

Bachelor’s degree in Life Sciences, Chemistry, Pharmacy, Microbiology, Engineering

Tools

TrackWise

Veeva QMS

Electronic quality systems

Jobbeschreibung

Nivagen Pharmaceuticals is seeking a QA/QMS Senior Specialist to lead deviations and investigations for sterile GMP manufacturing. You will own the lifecycle from initiation to closure, perform root cause analyses, and ensure FDA/cGMP compliance while coordinating across QA, QC, Engineering, and Validation teams.

The role requires strong investigative skills, technical writing ability, and experience with TrackWise or similar QMS systems, aiding inspection readiness and process improvements.