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Quality Assurance Manager

Clinical, Quality Assurance Manager                                     

The Quality Assurance Manager performs duties to ensure the quality management system at our client’s site is in compliance with requirements identified by Clinical Laboratory Improvement Amendments (CLIA), College of American Pathologists (CAP), as well as any other applicable laws, statutes, laws, regulations and individual contract requirements.

This position may require 20% travel to Connecticut and Ohio.

Responsibilities: 

  • Develop and participate in a Vendor Management Program; including auditing critical vendors where needed
  • Develop and maintain a complaint process program for client feedback and complaint investigation
  • Assist in the development, review and approval of verification plans for the lab equipment and assays
  • Writing report summaries and data review for validation and verification activities
  • Assist in the maintenance of the document control system by publishing and processing controlled documents through the electronic  document management system
  • Assist the Sr. Manager of Quality in the auditing program (internal, client specific, and regulatory)
  • Data gathering and review for metrics
  • Gap analysis of regulatory requirements versus current practice
  • Quality Event Reporting and CAPA

Education:

  • Minimum Associates degree in scientific discipline.

Experience:

  • At least 5 years of experience in a Quality Assurance role in a clinical laboratory setting.
  • Document control, change management, and report writing required.
  • Must have working knowledge of Microsoft Applications (Word, Excel, Office, and PowerPoint). Knowledge of CAP and CLIA regulations is required.
  • Assay and Equipment Validations and Verifications

Working Conditions: 

The primary working condition associated with this position is working independently in the office environment. While completing Quality Assurance / Validation activities, it is frequently required to work cross-functionally; and/or to enter and work in the Laboratory, in which the conditions may be variable from day to day. Travel may be required up to 20%.

Pay is negotiable based on experience.

Applicants can also send resume to Pittsburgh@apexlifesciences.com or contact 412-321-1143.
 

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