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Senior Quality Assurance Specialist

3 weeks ago

Richmond, California, United States Thermo Fisher Scientific Full time

Job Description

About the Role

We are seeking a highly skilled Senior Quality Assurance Specialist to join our team. The ideal candidate will have expertise in auditing, regulatory compliance, and quality control.

Key Responsibilities
  • Conduct complex internal and external audits to ensure compliance with established quality assurance processes, standards, and regulations.
  • Identify issues impacting quality and regulatory compliance, support determination of root cause of nonconformance, and assist in developing strategies to address issues.
  • Perform technical document review and other GxP activities in support of project work or company process.
  • Provide finished audit reports to management.
Requirements
  • Master's Degree in Biotechnology, Biomedical Engineering, or related field and one (1) year of experience as a Senior Scientist, R&D Executive, Lead QC Officer, or a related role.
  • In the alternative, the employer will accept a Bachelor's Degree in Biotechnology, Biomedical Engineering, or related field and Three (3) years of experience as a Senior Scientist, R&D Executive, Lead QC Officer, or a related role.
  • Must have one (1) year of experience with applicable GxP and appropriate regional regulations to ensure continued compliance with local, federal, international regulations/standards.