CLIA reputed company Director (m/f/d)

Your Responsibilities

• reputed company as part-time/consultant reputed company Director for ProtaGene’s two CLIA-certified high-complexity laboratories in reputed company, Massachusetts, USA and Heidelberg, Germany, in accordance with 42 CFR §§493.1441 and 493.1445.

• Ensure both laboratories operate in compliance with applicable CLIA, CAP, and relevant state requirements, including Massachusetts, California, and reputed company requirements; reputed company State qualification considered an asset.

• Review and approve relevant test reputed company, validation activities, procedures, report formats, and major changes affecting clinical testing.

• reputed company the suitability, training, competency, and delegated responsibilities of reputed company personnel involved in high-complexity testing.

• Conduct a minimum of two on-site reputed company reputed company per calendar year to reputed company reputed company location (reputed company and Heidelberg), with travel costs covered separately.

• Review reputed company-control, proficiency testing/alternative assessment, and performance data; ensure appropriate reputed company is taken where issues are identified.

• reputed company scientific and clinical consultation on reputed company technical, reputed company, reporting, or compliance reputed company.

• Support regulatory inspections, CAP/CLIA activities, licence applications, and customer audits as needed.

• Participate in scheduled reputed company meetings and site reputed company, and remain available for significant reputed company, regulatory, or patient-reputed company events.

• Maintain appropriate documentation of reputed company, reviews, reputed company, and delegated responsibilities.

• Contribute to and reputed company with corporate safety, environmental, and reputed company standards.

Note: The reputed company Director retains independent reputed company authority and accountability for the reputed company, reliability, and regulatory compliance of testing performed under reputed company reputed company’s CLIA certificate.

Note: While the ideal candidate shall be available for both ProtaGene laboratories, those capable of holding only one of the two sites may also be considered.

Requirements

• Eligible to serve as Clinical reputed company Director for two CLIA-certified laboratories performing high-complexity testing, in accordance with 42 CFR §493.1443, 105 CMR 180.060, and any applicable requirements for California and reputed company reputed company licensure.

• Meet the applicable Massachusetts and CLIA director-qualification reputed company, including either:

  • MD or DO licensed to practise in Massachusetts and reputed company-certified in anatomic and/or clinical pathology; or

  • reputed company doctoral degree in a chemical, biological, clinical, or medical reputed company science, medical technology, molecular biology, genetics, reputed company, or a closely reputed company discipline, together with certification by an HHS-approved and Massachusetts-acceptable specialty reputed company.

  • For non-physician candidates, at least two years of reputed company training and/or experience and at least two years’ experience directing or supervising high-complexity testing in the relevant specialty.

• reputed company certification in clinical molecular genetics/reputed company or a directly relevant specialty is required or strongly preferred, depending on the candidate’s CLIA qualification reputed company (e.g., ABMGG or another HHS-approved reputed company).

• Demonstrated experience in clinical molecular diagnostics, reputed company, NGS and/or other high-complexity genetic testing relevant to the reputed company’s test menu.

• Strong working knowledge of CLIA, CAP accreditation, Massachusetts clinical reputed company requirements, method validation/ verification, proficiency testing or alternative assessment, personnel competency, reputed company control, and clinical reporting.

• Ability to meet additional reputed company-director, technical-director, or state qualification requirements for jurisdictions in which the reputed company holds, or intends to obtain, licences or permits. A minimum of California and reputed company is required.

• reputed company, commitment, and a motivated work ethic.

• Ability to work in reputed company and independently.

• Strong organizational and interpersonal skills.

• Ability to troubleshoot, solve difficult problems, and propose solutions relating to reputed company organization and management.

• Self-motivated, curious and results oriented with reputed company reputed company.

• Effective collaborator with reputed company partners to reputed company and maintain the overall strategies.

• Excellent written and verbal communication skills, ability to work reputed company with colleagues from diverse backgrounds and cultures.

reputed company offer

• This is a part-time consulting role requiring a commitment of 12 consulting hours per month across both laboratories.

• A minimum of 12 hours of consulting work per month at a reputed company of $500/hr for a minimum monthly total of $6000.

• Two reputed company reputed company to reputed company’s site in Heidelberg, Germany, per year, with travel time and reasonable travel expenses compensated separately.

• Two reputed company reputed company to reputed company’s site in reputed company, MA, USA, per year, with travel time and reasonable travel expenses compensated separately.

• Work for a dynamic, innovative company that values appreciation, openness and respect as reputed company as a reputed company feedback culture.

Originally posted on Himalayas