QA Specialist

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 have remained steadfast in our commitment to core values of excellence, integrity, and respect for people. Our team collaborates 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 dedication to excellence, we 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.

Our mission is to make a meaningful difference in people’s lives by delivering high-quality, affordable medications while upholding the highest standards of integrity and excellence.

Nivagen Pharmaceuticals Inc.
3900 Duckhorn Drive, Sacramento, CA 95834

Title of the Position:
QA Specialist

As a Quality Assurance (QA) Specialist, you will play a critical role in ensuring that all products, processes, and documentation meet established quality standards, regulatory requirements, and company policies. Your responsibilities include maintaining compliance with cGMP, GLP, and other industry regulations, safeguarding product integrity, and supporting continuous improvement initiatives. You will manage Quality Management Systems (QMS), review critical documentation, oversee training programs, and ensure adherence to organizational quality objectives.

• Collect and analyse information to identify actual and potential product and quality problems, work with the Site Quality Lead Team to take corrective and preventive actions (CAPA), and verify and validate CAPA effectiveness.
• Lead, mentor, and coach operations and support personnel on Change Control, Deviation Management, and CAPA programs.
• Drive complete root cause investigations and ensure assignment of corrective and preventive actions to prevent recurrence.
• Create and maintain the CAPA program, working cross-functionally with area/function owners to include data sources that identify existing and potential problems.
• Compile and present CAPA program health metrics to the Site Quality Lead Team with proposed actions.
• Monitor deviation and CAPA performance to ensure timely investigations and CAPA completion.
• Act as a site instructor for Change Control, Deviation Management, and CAPA courses.
• Coach lead investigators on technical writing.
• Author periodic reviews and act as Subject Matter Expert for site CAPA and Deviation Management procedures.
• Support and initiate deviations, trends, or other technical investigations as applicable.
• Engage site personnel in the relationship between the CAPA program and product and process improvement.
• Implement electronic Quality Management System (eQMS) across the organization.
• Performs additional duties as assigned by the reporting manager.

Education/

Experience:

• Bachelor's degree in Pharmacy, Chemistry, Microbiology, Biotechnology, or a related discipline.
• Minimum 1–3 years of experience in Quality Assurance or a related field in a regulated industry (pharmaceuticals, biotechnology, or healthcare preferred).

Knowledge, Skills, and Abilities:

• Strong knowledge of cGMP, GLP, and quality standards such as ISO 9001.
• Proficiency in managing Quality Management Systems (QMS).
• Familiarity with laboratory instruments and analytical methods.
• Experience with document control processes and regulatory audits.
• Excellent attention to detail and strong organizational skills.
• Effective communication and interpersonal skills for collaboration across departments.
• Strong analytical and problem-solving abilities.
• Ability to work independently and as part of a team in a fast-paced environment.
• Proficient in Microsoft Office Suite (Word, Excel,…