In Process Quality Assurance Specialist

2 weeks ago


Sacramento, California, United States Nivagen Pharmaceuticals Full time
About the Job

We are seeking a highly skilled In Process QA Specialist to join our team at Nivagen Pharmaceuticals. As a key member of our quality assurance team, you will be responsible for ensuring that our pharmaceutical products meet the highest quality standards during the manufacturing process.

Key Responsibilities
  • Monitor and control critical quality attributes during production to prevent quality deviations
  • Conduct real-time testing and verification of in-process samples to ensure compliance with Good Manufacturing Practices (GMP) and regulatory requirements
  • Develop and implement standard operating procedures (SOPs) to ensure consistency and accuracy in production processes
  • Collaborate with production, quality control, and engineering teams to resolve quality issues and implement process improvements
  • Ensure that all in-process activities are documented and conducted in accordance with regulatory guidelines and company SOPs
Requirements
  • Bachelor's or Master's degree in Pharmaceutical Sciences, Chemistry, Biochemistry, Biotechnology, or related field
  • Minimum 2-5 years of experience in in-process quality assurance or a related role within a pharmaceutical or GMP-regulated environment
  • Strong analytical and problem-solving skills, with experience in root cause analysis and CAPA implementation
  • Excellent communication and collaboration skills, with ability to work effectively in a cross-functional team
What We Offer
  • Competitive salary range $75,000-$85,000 per year
  • Yearly bonus eligibility
  • Comprehensive benefits package, including medical, dental, and vision coverage, paid time off, and 401k savings plan
About Nivagen Pharmaceuticals

Nivagen Pharmaceuticals 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. We prioritize our employees' well-being by offering competitive pay, comprehensive benefits, and robust training and development opportunities.



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