Quality Assurance Specialist

1 week ago


Vacaville, California, United States Polaris Pharmaceuticals Inc. Full time

ROLE SUMMARY

The Quality Assurance Specialist at Polaris Pharmaceuticals Inc. plays a crucial role in ensuring the quality of our products. This position is responsible for maintaining quality requirements in accordance with regulatory guidelines and cGMP standards. As a quality liaison, the specialist will work closely with other departments to ensure seamless operations.

KEY RESPONSIBILITIES

  • Approve or reject intermediate materials for further manufacturing use
  • Review and approve procedures, specifications, and changes impacting product quality
  • Conduct investigations for deviations and discrepancies in manufacturing records
  • Assist with audits and provide subject matter expertise as needed
  • Disposition raw materials and provide QA support for quality issues
  • Review stability data and reports
  • Develop and maintain SOPs related to Quality Assurance
  • Assist with visual inspection of vials and labeled/packaged product materials
  • Review environmental, personnel, purified water, and clean steam monitoring results
  • Maintain the QA Document Archive and active quality system files
  • Develop subject matter expertise in quality systems and train junior staff
  • Stay up-to-date with cGMP, 21CFR, USP, EP, ICH, and other regulatory requirements
  • Provide trend analysis and critical thinking to quality systems
  • Support product shipping, including generation of shipping documents

REQUIREMENTS

  • Bachelor's degree in Science or related field (with relevant quality system experience)
  • Master's degree in Science or related field (with 4-8 years of quality system experience)
  • PhD in Science or related field (with 3-5 years of quality system experience)


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