Compliance Manager for Quality Control Laboratory

5 days ago


Summerville, Oregon, United States Thorne Research Full time
Job Title: Quality Control Laboratory Compliance Manager

At Thorne Research, we are committed to providing personalized health solutions and cutting-edge home health test technology. We are seeking a highly skilled Quality Control Laboratory Compliance Manager to join our team.

Job Summary:

This role is responsible for managing and supporting the implementation of overall laboratory compliance, including GMP and data integrity programs for laboratory operations and all laboratory systems. The successful candidate will work closely with QC Laboratory Management and Quality Assurance to ensure compliance with external regulators and internal policies.

Key Responsibilities:
  • Manage and lead activities to ensure compliance with current and new/revised standards, regulations, and policies.
  • Oversee the quality activities for laboratory compliance with cGMP, ISO 17025, and regulatory requirements.
  • Support instrument laboratory software validation activities in the QC Laboratories.
  • Ensure compliance with laboratory software testing and validation requirements.
  • Monitor, trend, and track QC laboratory metrics for Investigations (OOS), CAPAs, ETRs, and other relevant quality systems.
  • Actively participate in process improvement initiatives aiming for RFT on documentation and OOS/Deviation/NCM reduction in collaboration with Quality management.
  • Responsible for escalation of OOS investigations within QC laboratory and will develop and implement long-term strategies and continuous improvements for QC Laboratory Compliance.
Requirements:
  • Bachelor's degree (BS/BA) in chemistry, biochemistry, microbiology, or related science discipline.
  • Prior supervisory and/or managerial experience in laboratory compliance in a cGMP or ISO laboratory environment.
  • Prior experience in testing and release of chemicals/pharmaceuticals/dietary supplement products is desirable.
What We Offer:

At Thorne Research, we offer employees the chance to work with great people on exciting projects, with opportunity for growth. We also provide a full range of benefits for you and your eligible family members, including competitive compensation, 100% company-paid medical, dental, and vision insurance coverage, and a safe and clean work environment.

We are committed to providing personalized health solutions, cutting-edge home health test technology, and superior supplements. To do that, Thorne Research owns every step of its business, from R&D to product delivery and customer service. Currently, we are:

  • The only company with exclusive partnerships with the Mayo Clinic and U.S. Olympic teams.
  • The #1 prescribed practitioner brand to 30 to 40-year-olds.
  • The #2 most dispensed supplement brand.
  • The fastest growing supplement company with sales on Amazon; the #1 practitioner brand; with an average ranking of 4.42 of 5 stars.

If you want to make a difference in the lives of others, consider becoming part of the Thorne Research team.



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