Quality Assurance Specialist II

92618, Irvine
Jun 07, 2022
Required Education
Bachelors Degree
Position Type
Full time

Review GMP technical documentation to ensure quality standards are met and compliant with applicable SOPs, US FDA 21CFR210, 211, 11 and applicable ICH guidance documents.  Develop and revise QA procedures to strengthen cGMP compliance.


  • Performing timely review of batch records, test results and supporting technical documentation. Work closely with QA management to proactively address the quality of documentation. 
  • Collaborating effectively with operations management to review and approve: SOPs, protocols, reports, equipment qualifications and calibrations, change controls, specifications, and other quality, documentation.
  • Providing assistance during cGMP compliance inspections of the facility by clients, the FDA and/or other regulatory bodies. This includes coordinating the retrieval of quality documents/records/trend data and any other documentation requested during these inspections.
  • Providing support for execution of the supplier assurance program at the site
  • Supporting review and release of raw materials and final product.
  • Providing cGMP compliance guidance and advice as needed.
  • Reviewing and approve deviations.
  • Supporting QA management in gathering data necessary for tracking quality metrics.
  • Maintaining workspace cleanliness by adhering to the 5S method of organization.
  • Abiding by safe work practices and adhere to general safety rules, performing all duties in a safe manner and never placing yourself or those around you in an unsafe condition. Report all unsafe conditions to your supervisor.

Qualifications - Experience & Education:
2 – 3 years industry related work experience preferred.
Bachelor's degree or equivalent in scientific discipline required.