In Process Quality Assurance Specialist

1 month ago


Sacramento, California, United States Nivagen Pharmaceuticals Full time
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. Our commitment to core values of excellence, integrity, and respect for people drives our team of professionals to pioneer advancements in manufacturing, distribution, and quality control.

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.

Job Description

The In Process QA Specialist will be responsible for ensuring that pharmaceutical products meet quality standards during the manufacturing process. This role involves real-time monitoring, sampling, testing, and documentation to identify and address any quality issues as they arise.

The ideal candidate will have a strong analytical and problem-solving skills, with experience in root cause analysis and CAPA implementation. They will also have a high level of attention to detail, proficiency in using quality testing equipment, and familiarity with statistical process control (SPC) methods.

The In Process QA Specialist will work closely with production, quality control, and engineering teams to resolve quality issues and implement process improvements. They will also collaborate with supplier quality management to ensure that raw materials and components meet quality requirements.

Responsibilities
  • Identify and oversee critical control points in the manufacturing process to prevent quality deviations
  • Continuously monitor production processes to ensure that manufacturing team operate within specified parameters and meet quality standards
  • Collect in-process samples at various stages of production for testing and verification
  • Coordinate in-process testing of intermediate products for critical quality attributes
  • Oversee environmental monitoring in cleanrooms and other controlled areas
  • Review and verify the completeness and accuracy of batch production records
  • Document any deviations or non-conformances detected during production
  • Lead or support investigations into process deviations
  • Implement and monitor corrective and preventive actions (CAPA)
  • Ensure compliance with GMP, FDA, EMA, and other relevant regulatory standards
Requirements
  • Bachelor's or Master's degree in Pharmaceutical Sciences, Chemistry, Biochemistry, Biotechnology, or related sciences
  • Minimum of two to five 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
  • High level of attention to detail
  • Proficiency in using quality testing equipment
  • Familiarity with statistical process control (SPC) methods
Benefits
  • Competitive pay range $75,000-$85,000 per year
  • Yearly bonus eligibility
  • Comprehensive benefits package
  • Paid time off plan
  • 401k savings plan


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