Nivagen Pharmaceuticals, Inc.
QA/QMS Senior Specialist — Deviations & Investigations
Sacramento, CA 95834 · Senior
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odds of building a lasting career here
Sponsors, but it's cap-subject — you still face the weighted lottery (~30% per draw at Level II). Good if you win; have a cap-exempt backup on your list.
Lottery odds assume a STEM candidate.
Personalize to your clock →H-1B wage level
the lottery is wage-weighted — each level is one more entry
$1,578 more — $81,578 — moves this role to Level II and 2 lottery entries. That figure is inside the range the employer already advertised.
Based on the DOL prevailing wage for this occupation and worksite, a base salary of $81,578 would place this position at wage Level II. That figure is within the posted range, and I'd like to target it. This role classifies under "Compliance Officers" for prevailing-wage purposes.
DOL prevailing wage, 2026-27 wage year · Compliance Officers (13-1041) · Sacramento-Roseville-Folsom, CA. Wage level is derived by USCIS from the offered wage, occupation and worksite; the occupation shown is inferred from the job title.
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About the role
- 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.
Responsibilities
- Own the deviation lifecycle from initiation through investigation, root cause analysis, corrective action identification, and closure within established timelines.
- Support internal audits and FDA/regulatory inspections by providing deviation records, trending data, and investigation summaries.
- We are focused on building a diverse and inclusive workforce.
Requirements
- 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).
- 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
- Hands-on experience investigating sterile-specific deviations including media fill failures, environmental monitoring excursions, filter integrity test failures, particulate contamination, and aseptic processing breaches.
- ICH Q7 and Q10
- and FDA guidance on investigating deviations.
- Competitive salary and comprehensive benefits package.
- Opportunity to build QMS infrastructure from the ground up at a growing pharmaceutical company.
Nice to have
- 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.
Compensation
- Pay range $80,000-$90,000 per Year
Benefits
- 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
Company info
- Nivagen is a global company dedicated to enhancing lives by developing and providing cost-effective generic prescription drugs and over-the-counter products for the North American market.
- For over a decade, we've remained steadfast in our commitment to core values of excellence, integrity, and respect for people.
- Our team of professionals collaborates tirelessly to pioneer advancements in manufacturing, distribution, and quality control, ensuring a holistic approach to healthcare.
- Through vertical integration of the pharmaceutical supply chain, cutting-edge technology, and unwavering dedication to excellence, we continually strive to redefine medication accessibility and affordability.
- We prioritize our employees' well-being by offering competitive pay, comprehensive benefits, and robust training and development opportunities.
- By investing in our workforce and fostering a culture of growth and support, we empower our team to drive innovation and make a positive impact in the healthcare industry.
- At Nivagen, our mission is clear: to make a meaningful difference in people's lives by delivering high-quality, affordable medications while upholding the highest standards of integrity and excellence.
- Job Location:
- Nivagen Pharmaceuticals Inc., Sacramento, CA
- 3900 Duckhorn Dr, Sacramento, CA 95834
- Position Summary
- 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.
Visa & Work Authorization
- iduals 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 s
This listing is sourced directly from Nivagen Pharmaceuticals, Inc.'s careers page and normalized into a canonical job model.