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Laboratory Director

Employer
Perkin Elmer
Location
Branford CT US
Closing date
Aug 17, 2016

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Sector
Pharmaceutical
Hours
Full Time
Organization Type
Corporate
PerkinElmer is currently seeking a Laboratory Director who is board-certified in Clinical Molecular Genetics, to help head our new clinical laboratory. This individual will ensure that the laboratory consistently provides accurate and reliable patient test results and reports. Responsibilities associated with the position include assuring that regulatory obligations, including quality control and quality assurance functions, are properly performed. In addition, as a member of PerkinElmer’s laboratory operations team, you will help ensure that the laboratory properly deploys and validates CLIA and CAP compliant tests.

Responsibilities:
  • Review, approve, and sign-out reports for a variety of sequencing-based clinical tests
  • Interpret NGS and confirmatory results in the context of medical literature, online variant databases and other references along with relevant patient demographic data.
  • Assist in the preparation and release of test reports.
  • Help set quality standards for laboratory operations and acceptable levels of analytic performance to ensure that these are maintained.
  • Ensure that QC, QA, and QI practices remain consistent with company policies, state, local, and federal regulatory standards and ACMG and other professional practice guidelines.
  • Ensure proper proficiency testing and implement relevant corrective actions.
  • Develop and/or review and approve lab SOPs.
  • Provide vital clinical oversight for daily operations of the Branford, CT laboratory with continual evaluation and improvement of laboratory strategies and protocols.
  • Help evaluate and refine the set of diseases and variants for which company offers services as well as diagnostic and screening reports.
  • Be responsible for CLIA, CAP, and state DOH audits and submissions for the facility.
  • Work in conjunction with the R&D team to oversee validation of new tests and assist with the transition to clinical testing.

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