Quality Assurance Specialist
1 week ago
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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