Senior QA/QMS Deviations & Investigations Lead

Nivagen Pharmaceuticals Inc; Sacramento (CA); Sur place; USD 80 000 - 90 000; Plein temps

Avantages offerts par ce poste

Competitive pay

Comprehensive benefits

Bonus eligibility

Medical coverage

Dental coverage

Vision coverage

Paid time off

Career growth

Résumé du poste

Nivagen Pharmaceuticals Inc. is seeking a QA/QMS Senior Specialist - Deviations & Investigations to lead deviations across sterile GMP manufacturing.

You will manage initiation, investigation, root cause analysis, and closure in compliance with FDA/cGMP requirements, serving as the central contact for deviation lifecycle management. Responsibilities include thorough root cause analysis, writing investigation narratives, IQAs, and final deviation reports in TrackWise, plus coordinating with QA

Qualifications

• Bachelor's degree in Life Sciences, Chemistry, Pharmacy, Microbiology, Engineering, or a related field.
• 7–10 years of QA experience in deviation investigations in sterile pharmaceutical manufacturing.
• Proficient in root-cause analysis tools (Ishikawa, 5-Why, FMEA, fault tree).
• Experience with sterile manufacturing deviations (media fill, environmental monitoring, aseptic processing).
• Familiar with TrackWise, Veeva QMS, or similar systems.
• Strong written communication for FDA-defensible reports.
• Knowledge of 21 CFR Parts 210, 211, 212; ICH Q7/Q10; FDA deviation guidance.

Responsabilités

• Own deviation lifecycle from initiation to closure within timelines.
• Act as primary contact for deviation activities across departments.
• Conduct root cause analyses using Ishikawa, 5-Why, and fault tree methods.
• Author investigation narratives, IQAs, and deviation reports in TrackWise.
• Classify deviations by severity and assess impact on product quality and regulatory compliance.
• Coordinate batch disposition with QA batch release and QC teams.
• Identify trends and escalate to CAPA for systemic issues.
• Support audits/inspections with deviation records and summaries.
• Ensure ALCOA+ data integrity and 21 CFR Part 11 compliance.

Connaissances

QA experience

Deviation investigations

Root cause analysis

TrackWise

Veeva QMS

FDA 21 CFR knowledge

Technical writing

Formation

Bachelor's degree in Life Sciences/Pharmacy/Engineering

Outils

TrackWise

Veeva QMS

Description du poste

Nivagen Pharmaceuticals Inc. is seeking a QA/QMS Senior Specialist - Deviations & Investigations to lead deviations across sterile GMP manufacturing.

You will manage initiation, investigation, root cause analysis, and closure in compliance with FDA/cGMP requirements, serving as the central contact for deviation lifecycle management. Responsibilities include thorough root cause analysis, writing investigation narratives, IQAs, and final deviation reports in TrackWise, plus coordinating with QA