QA/QMS Senior Specialist — Deviations & Investigations

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About the role

About the Company: 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. 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. Key Responsibilities • Own the deviation lifecycle from initiation through investigation, root cause analysis, corrective action identification, and closure within established timelines. • Serve as the primary point of contact for all deviation-related activities across Manufacturing, Quality Control, Engineering, and Validation departments. • Conduct thorough root cause analyses using structured methodologies including Ishikawa (6M), 5-Why, and fault tree analysis. • Author investigation narratives, initial quality assessments (IQAs), and final deviation reports in TrackWise. • Classify deviations by severity (Critical, Major, Minor) and assess impact on product quality, patient safety, validated state, and regulatory compliance. • Coordinate batch disposition activities in collaboration with QA batch release and QC laboratory teams. • Identify recurring deviation trends and escalate to the CAPA system when systematic issues are identified. • Track and report deviation KPIs including open aging, cycle time, recurrence rates, and root cause categories during management review. • Support internal audits and FDA/regulatory inspections by providing deviation records, trending data, and investigation summaries. • Ensure all deviations comply with ALCOA+ data integrity principles and 21 CFR Part 11 requirements for electronic records. • Serve as a trained backup for related QMS subsystems (CAPA and Change Control), providing cross-functional coverage during peak workload periods, absences, or as needed to ensure continuity of quality operations. 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

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