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QA Manager

Company: Labcorp
Location: South San Francisco
Posted on: July 13, 2021

Job Description:

Monogram Biosciences (part of LabCorp), is seeking a QA Manager to join its team in South San Francisco. The QA Manager is an integral member of the Quality leadership team and will partner with other members of the team to provide oversight and ensure effectiveness of Monogram's Quality Management System (QMS). The QA Manager will be primarily responsible for the management and continuous improvement of Monogram's Quality Management System with an emphasis on CAP/CLIA, NY, Part 820 and GxP compliance.

Reporting to the Director of Quality, this position will require routine coordination with multidisciplinary functional and project teams dedicated to building and improving Monogram's QMS while providing products & services to our partners. Experience in CAP/CLIA, ISO 15189/13485 and Part 820 QSR is preferred.


Responsibilities:

  • Develop, implement and provide continuous improvement of paper and electronic quality systems in compliance with applicable regulatory requirements.
  • Represent QA in functional team meetings; provides guidance and recommendations in alignment with regulatory and project requirements
  • Responsible for the maintenance and continuous improvement of Quality Essentials such as the internal audits and proficiency testing programs, Occurrences and CAPA systems, document control and quality records, etc.
  • Author and revise standard operating procedures and other controlled documents
  • Identify opportunities for improvement, and drives continuous improvement initiatives
  • Provide trends and report key quality metrics to the leadership team
  • Management of other Quality functions as designated

Keywords: Labcorp, South San Francisco , QA Manager, Other , South San Francisco, California

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