QMS Associate

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 the 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, Sacramento, CA

3900 Duckhorn Dr, Sacramento, CA 95834

About the Job:

Title of the Position: QMS Associate

As a QMS Associate at Nivagen, you are responsible for coordinating and supporting the lifecycle management of deviations within the Quality Management System (QMS). This role ensures timely documentation, investigation support, root cause analysis facilitation, and CAPA tracking in compliance with cGMP, FDA regulations, and internal quality standards. The Associate works cross-functionally with Manufacturing, Engineering, QC, and Validation teams to ensure quality events are appropriately investigated, documented, and closed within established timelines.

Responsibilities:

• Manage the intake, triage, and processing of deviations within the electronic Quality Management System (eQMS).
• Perform initial impact and risk assessments to determine deviation classification and required investigation level.
• Coordinate cross-functional investigations to ensure timely root cause analysis and documentation.
• Support the development, tracking, and effectiveness verification of Corrective and Preventive Actions (CAPAs).
• Ensure deviations are investigated and closed within established timelines and escalate overdue records as necessary.
• Review investigation reports for completeness, technical accuracy, regulatory compliance, and data integrity.
• Identify recurring trends and support periodic reporting on quality metrics.
• Participate in Quality Risk Assessments (e.g., FMEA) related to deviations and product impact evaluations.
• Support regulatory inspections and internal audits by providing deviation records and investigation summaries.
• Maintain compliance with cGMP (21 CFR Parts 210/211), data integrity principles, and company quality procedures.
• Assist in continuous improvement initiatives to enhance deviation management processes and reduce recurrence.

Qualifications:

• Bachelor’s degree in Life Sciences, Engineering, Pharmacy, or related field
  OR equivalent GMP manufacturing/quality experience.
• 0–3 years of experience in pharmaceutical, biotech, or regulated manufacturing environments.
• Basic knowledge of cGMP and FDA regulations (21 CFR).
• Familiarity with deviation management, CAPA systems, and root cause analysis tools preferred.
• Strong understanding of sterile manufacturing processes, aseptic techniques, environmental monitoring, and contamination control principles.
• Experience with TrackWise electronic Quality Management Systems preferred.
• Strong analytical and problem-solving skills.
• Excellent written and verbal communication skills.
• Strong attention to detail and organizational skills.
• Proficiency in Microsoft Office applications.

Knowledge, Skills, and Abilities:

• Understanding of risk management principles (ICH Q9).
• Exposure to investigation methodologies (5-Why, Fishbone, Fault Tree Analysis).
• Ability to interpret manufacturing, laboratory, and validation data.
• Experience supporting FDA inspections or internal audits.
• Ability to work collaboratively across departments while maintaining quality oversight and objectivity.

Job Requirements:

• The role involves working in both office and manufacturing environments, requiring adherence to safety protocols and GMP standards
• Occasional travel may be required for audits, supplier evaluations, or training
• Must live or be willing to move to the Sacramento Metropolitan Region (Approx. 40 miles’ radius)

Benefits:

• Pay range $70,304 - $80,000 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
• 401k savings 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.