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Quality Assurance Specialist

2 months ago

Rochester, New York, United States Insight Global Full time
Quality Assurance Specialist Opportunity

Insight Global is seeking a skilled Quality Assurance Specialist to join their team at a leading biotech company in Rochester, Minnesota. The ideal candidate will have a strong background in GxP and/or Clinical Laboratory Improvement Amendments (CLIA) experience.

Key Responsibilities:

  • Implement and maintain ISO 9001 environments in a biotech or biopharma setting.
  • Ensure compliance with GMP, GLP, and/or GCP regulations.
  • Collaborate with cross-functional teams to drive quality initiatives.

Requirements:

  • Bachelor's degree in a science-related field or quality assurance.
  • 4+ years of experience in an ISO 9001 environment from a biotech or biopharma company.
  • Strong experience with eQMS systems (Qualio).

Preferred Qualifications:

  • Experience implementing an ISO 9001 environment.
  • Experience with ISO 17025 and/or ISO.

About Insight Global:

Insight Global is a leading provider of viral and cellular products and research services with a focus on viro-immunotherapies and correlative testing for clients who perform oncolytic virus clinical trials.