Quality Assurance QMS Specialist - Parenteral

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. Over a decade, we have remained steadfast in our commitment to excellence, integrity, and respect for people. Our professionals collaborate to pioneer advancements in manufacturing, distribution, and quality control for 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 employee well‑being by offering competitive pay, comprehensive benefits, and robust training and development opportunities, fostering a culture of growth and support that empowers the team to drive innovation and impact healthcare positively.

Nivagen Pharmaceuticals, Sacramento, CA
3900 Duckhorn Dr, Sacramento, CA 95834

Title:

Quality Assurance QMS Specialist – Parenteral

As a Quality Assurance QMS Specialist – Parenteral, you will support the development, implementation, and maintenance of the Quality Management System (QMS) in compliance with regulatory requirements and industry standards. This role involves analyzing quality data, managing documentation, coordinating audits, and driving continuous improvement initiatives to ensure the highest standards of product quality and regulatory compliance within the pharmaceutical industry.

• Collect and analyze information to identify actual and potential product and quality problems, working with the Site Quality Lead Team to implement corrective and preventive actions and verify and validate the effectiveness of CAPA.
• Lead, mentor, and coach operations and support personnel on the Change Control, Deviation Management system, and CAPA program.
• Drive root‑cause investigations and assign corrective and preventive actions to eliminate root causes of detected issues and prevent recurrence.
• Create and maintain the CAPA program by collaborating with all 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 investigations and associated CAPA are completed promptly.
• Act as a site instructor for Change Control, Deviation Management, and CAPA courses.
• Coach lead investigators on technical writing.
• Author periodic reviews and serve as a 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 resulting product and process improvement and enhanced understanding.
• Work with the network deviation program mentor to benchmark and replicate best practices.
• Implement the electronic QMS (eQMS) effectively across organizations.

• Preferred:
  Bachelor's or Master's degree in Pharmaceutical Sciences, Chemistry, Biochemistry, Biotechnology, or related sciences from an accredited institution.
• Required:
  
  2–5 years of experience in in‑process quality assurance or a related role within a pharmaceutical or GMP‑regulated environment, or equivalent experience in related fields.

• Strong understanding of pharmaceutical regulations, including FDA, EMA, GMP, and ICH guidelines.
• Proficient in data analysis with the ability to interpret complex quality data and identify trends.
• High level of accuracy and attention to detail, particularly in documentation and data analysis.
• Demonstrated ability to conduct root‑cause analysis and implement effective CAPAs.
• Excellent written and verbal communication skills, with the ability to prepare clear and concise reports and documentation.
• Familiarity with QMS software and other relevant tools used in quality management and data analysis.
• Ability to work effectively in a team environment and collaborate with cross‑functional teams.