Senior QA/QMS Specialist - Deviations & Investigations

Nivagen Pharmaceuticals, Inc.; Sacramento (CA); On-site; USD 80,000 - 90,000; Full time

Benefits offered by this job

Yearly bonus eligibility

Medical, dental and vision coverage

Paid time off plan

Professional development opportunities

Job summary

Nivagen Pharmaceuticals, Inc. in Sacramento, CA seeks a QA/QMS Senior Specialist - Deviations & Investigations to lead deviation management across sterile GMP manufacturing.

You will initiate, investigate, and close deviations per FDA/cGMP requirements, serving as the central contact for lifecycle management with cross-functional teams. Must have strong investigative writing, familiarity with TrackWise or Veeva QMS, and knowledge of 21 CFR Parts 210–212.

Qualifications

• Bachelor's degree in Life Sciences or related field.
• 7–10 years of QA experience with deviation investigations in sterile pharma manufacturing.
• Hands-on experience with root cause analysis methods (Ishikawa, 5-Why, FMEA, fault tree).

Responsibilities

• Own deviation lifecycle from initiation to closure within timelines.
• Act as primary contact for deviation activities across QA, Manufacturing, and QC.
• Conduct root cause analyses using structured methods.
• Author investigation narratives and deviation reports in TrackWise.

Skills

Root cause analysis

Technical writing

Cross-functional coordination

Quality investigations tooling

Education

Bachelor's degree in Life Sciences/related field

Tools

TrackWise

Veeva QMS

Job description

Nivagen Pharmaceuticals, Inc. in Sacramento, CA seeks a QA/QMS Senior Specialist - Deviations & Investigations to lead deviation management across sterile GMP manufacturing.

You will initiate, investigate, and close deviations per FDA/cGMP requirements, serving as the central contact for lifecycle management with cross-functional teams. Must have strong investigative writing, familiarity with TrackWise or Veeva QMS, and knowledge of 21 CFR Parts 210–212.