QA/QMS Senior Specialist — Deviations & Investigations
Role Overview
Nivagen Pharmaceuticals is looking for a QA/QMS Senior Specialist - Deviations & Investigations to lead the deviation management process across sterile GMP manufacturing operations.
This individual will be responsible for the timely initiation, investigation, root cause analysis, and closure of deviations in compliance with FDA/cGMP requirements.
The role serves as the central point of contact for deviation lifecycle management and requires strong investigative skills, technical writing ability, and cross-functional coordination.
Full Job Posting
Qualifications
- Bachelor’s degree in Life Sciences, Chemistry, Pharmacy, Microbiology, Engineering, or a related field.
- Minimum 7-10 years of experience in QA, conducting deviation investigations in sterile pharmaceutical manufacturing.
- Demonstrated expertise in root cause analysis tools (Ishikawa, 5-Why, FMEA, fault tree analysis).
- Hands-on experience investigating sterile-specific deviations including media fill failures, environmental monitoring excursions, filter integrity test failures, particulate contamination, and aseptic processing breaches.
- Proficiency with TrackWise, Veeva QMS, or equivalent electronic quality management systems.
- Strong technical writing skills with the ability to author clear, concise, and FDA-defensible investigation reports.
- Working knowledge of 21 CFR Parts 210, 211, and 212; ICH Q7 and Q10; and FDA guidance on investigating deviations.
- Experience supporting FDA Pre-Approval Inspections (PAI) or routine GMP inspections is a plus.
- Working familiarity with adjacent QMS processes (CAPA and Change Control) is strongly preferred; willingness to cross-train across these subsystems is required.
- What We Offer
- Competitive salary and comprehensive benefits package.
- Opportunity to build QMS infrastructure from the ground up at a growing pharmaceutical company.
- Direct impact on FDA inspection readiness and commercial manufacturing success.
- Collaborative work environment with a supportive quality leadership team.
- Professional development and career growth opportunities.
Benefits:
- Pay range $80,000-$90,000 per Year
- Yearly bonus eligibility
- Benefits: Nivagen offers a wide variety of benefits and programs to support health and well-being
- Medical, dental and vision coverage
- Paid time off plan
- Additional Information:
- Nivagen to afford equal opportunity for employment to all individuals regardless of race, color, age, national origin, physical or mental disability, history of disability, ancestry, citizenship status, political affiliation, religion, gender, transgender, gender identity, marital status, status as a parent, sexual orientation, veteran status, genetic information or other factors prohibited by law, and to prohibit harassment or retaliation based on any of these factors.
- We are focused on building a diverse and inclusive workforce. If you're excited about this role, but do not meet 100% of the qualifications listed above, we encourage you to apply.
About Nivagen Pharmaceuticals
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