Quality Assurance Analyst

2 weeks ago


El Segundo, California, United States Unicon Pharma Inc Full time
Job Overview

Position Summary: This role is integral to the Quality Assurance team, focusing on maintaining adherence to established quality standards and regulatory frameworks. The successful candidate will report to the Senior QA Manager within the Quality Operations department.


Key Responsibilities:

  • Conduct thorough reviews of batch documentation to ensure any discrepancies are addressed prior to product release.
  • Perform detailed quality assessments of batches to determine their suitability for disposition.
  • Implement and monitor process control measures throughout the manufacturing cycle.
  • Oversee the initiation, investigation, and resolution of product-related deviations.
  • Facilitate the initiation and resolution of associated Corrective and Preventive Actions (CAPAs) as necessary.
  • Develop and revise operational procedures, forms, and documentation.
  • Represent the Quality Assurance team in plant and multi-site scheduling discussions.
  • Provide QA insights during multi-site disposition meetings.
  • Contribute QA expertise to project teams and meetings.
  • Maintain metrics related to product disposition to support management reviews and continuous improvement initiatives.
  • Assist in inspections and audits to ensure compliance with quality standards.


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