In Process Quality Assurance Specialist

4 weeks ago


Sacramento, California, United States Nivagen Pharmaceuticals Full time
Job Summary

Nivagen Pharmaceuticals is seeking a highly skilled In Process QA Specialist to join our team. 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 control points in the manufacturing process to prevent quality deviations
  • Collect and test 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 quality in our manufacturing processes
  • Collaborate with cross-functional teams to resolve quality issues and implement process improvements
  • Ensure compliance with GMP, FDA, and other relevant regulatory standards

Requirements:

  • Bachelor's or Master's degree in Pharmaceutical Sciences, Chemistry, Biochemistry, or related field
  • Minimum 2-5 years of experience in in-process quality assurance or related field
  • Strong analytical and problem-solving skills, with experience in root cause analysis and CAPA implementation
  • Excellent communication and collaboration skills

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 plan and 401k savings plan


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