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Clia Inspector Jobs in Boston, MA (NOW HIRING)

Foundation Medicine

Associate Laboratory Director

Boston, MA · On-site

$115K - $150K/yr

... CLIA, NYS, and ISO. Working in collaboration with the Laboratory Director, this role assists in regulatory readiness, inspections, corrective actions, and ongoing quality improvement activities. In ...

QUANTERIX CORP

Laboratory Informatics Analyst

Bedford, MA · On-site

$100K - $120K/yr

... inspection ready within CLIA/CAP/GxP/FDA regulated environments. WHAT YOU'LL DO: * Translate laboratory needs into clear, structured requirements for LIMS bug fixes, enhancements, and operational ...

Quanterix

Laboratory Informatics Analyst

Bedford, MA · Hybrid

$100K - $120K/yr

... inspection ready within CLIA/CAP/GxP/FDA regulated environments. WHAT YOU'LL DO: * Translate laboratory needs into clear, structured requirements for LIMS bug fixes, enhancements, and operational ...

Foundation Medicine

Senior Quality Engineer

Boston, MA · On-site

$101.20 - $126.50/hr

Support regulatory inspections and audits through retrieval of records and evidence. * Metrics and ... Experience operating under FDA QMSR, ISO 13485, ISO 15189, CLIA, CAP, and GxP environments.

Foundation Medicine

Senior Quality Engineer

Boston, MA

$101K - $126K/yr

Support regulatory inspections and audits through retrieval of records and evidence. * Metrics and ... Experience operating under FDA QMSR, ISO 13485, ISO 15189, CLIA, CAP, and GxP environments.

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Clia Inspector information

What is a Clia inspector?

A CLIA Inspector is responsible for ensuring that clinical laboratories comply with the regulations set by the Clinical Laboratory Improvement Amendments (CLIA). They conduct inspections, review laboratory procedures, and assess compliance with federal standards for accuracy and reliability in patient testing. Inspectors may also provide guidance to labs on maintaining proper certification and improving quality control measures.

What are the key skills and qualifications needed to thrive as a Clia inspector?

To thrive as a CLIA Inspector, you need a comprehensive understanding of laboratory science, regulatory standards, and quality assurance procedures, typically supported by a degree in a related field and experience in clinical laboratory environments. Familiarity with CLIA regulations, laboratory information management systems (LIMS), and inspection protocols is essential. Strong attention to detail, analytical thinking, and effective communication are vital soft skills for this role. These skills and qualifications are crucial to ensure laboratories maintain compliance, uphold high-quality standards, and deliver accurate patient results.

What are the most common challenges faced by a Clia inspector in the field?

CLIA Inspectors often face the challenge of staying current with evolving regulations and ensuring diverse laboratories consistently meet complex compliance standards. They must adapt to varied laboratory environments, each with its own unique procedures and potential issues, while managing tight inspection schedules. Additionally, inspectors communicate findings and recommendations to laboratory staff, which requires both technical expertise and strong interpersonal skills. Overcoming these challenges contributes to maintaining healthcare quality and patient safety.

What are the most commonly searched types of Clia Inspector jobs in Boston, MA?

The most popular types of Clia Inspector jobs in Boston, MA are:

What are popular job titles related to Clia Inspector jobs in Boston, MA?

For Clia Inspector jobs in Boston, MA, the most frequently searched job titles are:

What job categories do people searching Clia Inspector jobs in Boston, MA look for?

The top searched job categories for Clia Inspector jobs in Boston, MA are:

Clia Inspector jobs near you
Infographic showing various Clia Inspector job openings in Boston, MA as of August 2026, with employment types broken down into 72% Full Time, 20% Part Time, 6% Contract, and 2% Nights. Highlights an 95% Physical, 1% Hybrid, and 4% Remote job distribution.

High Complex CLIA LAB: Lab Director

Nanobiosym

Cambridge, MA

$115K - $151K/yr

Part-time

Re-posted 20 days ago

Job description

Nanobiosym is an innovative company in Cambridge, MA that is developing novel technologies to address a broad range of diseases. Nanobiosym was founded by an MIT/Harvard alum to work at the interface of physics, nanotechnology, and biomedicine. This hypergrowth company allows for unique career opportunities with strong long-term incentives. Nanobiosym is currently seeking top notch candidates to help the company scale up its operations.

seeking a part-time/full time Laboratory Director to support the establishment, certification, and operation of our CLIA-certified laboratory in Massachusetts. The Laboratory Director will provide clinical, scientific, and regulatory oversight to ensure Nanobiosym delivers accurate, reliable, and high-quality testing services in compliance with applicable regulatory and accreditation requirements, including CLIA, CAP, and other applicable state requirements.

The Laboratory Director will be responsible for overseeing laboratory QMS, ensuring appropriate validation and performance of all testing methods, reviewing laboratory procedures, and supporting continuous improvement initiatives. This role provides clinical and technical guidance for test interpretation, quality assurance and regulatory compliance.

This is a role intended to support Nanobiosym's CLIA/CAP certification readiness and clinical laboratory operations. The Laboratory Director may delegate specific duties to qualified personnel but retains the ultimate responsibility for ensuring these duties are properly performed and documented.

Responsibilities:

  • Serve as the CLIA Laboratory Director for our high-complexity clinical laboratory.
  • Provide overall clinical, scientific, and regulatory oversight of CLIA/CAP-certified laboratory operations.
  • Ensure compliance with all applicable regulatory and accreditation requirements, including CLIA, CAP, and NY State CLEP, as applicable.
  • Oversee quality management program to ensure accurate, reliable, and timely laboratory testing.
  • Review and approve laboratory policies, procedures, test validations, and quality documentation.
  • Monitor laboratory performance and implement continuous quality improvement initiatives.
  • Provide clinical consultation to physicians and other healthcare providers regarding laboratory testing and test results.
  • Support laboratory readiness for regulatory inspections and accreditation surveys.
  • Foster a culture of quality, compliance, and scientific excellence.

Qualifications

  • M.D., or Ph.D. in a relevant scientific discipline (e.g., immunology, pathology, clinical chemistry, biochemistry, molecular biology, or a related field).
  • Qualified to serve as Clinical Laboratory Director of a high-complexity CLIA/CAP laboratory under applicable federal and Massachusetts state regulations -- Clinical Laboratory Director License issued by the Massachusetts Department of Public Health (MDPH) is required
  • Board certification in a relevant discipline (e.g., Virology, Molecular Biology, Clinical Chemistry, Clinical Pathology, HCLD, Immunology, or other appropriate specialty) is required.
  • Minimum 8-10 years of experience in high complexity clinical laboratory operations, with at least 5 years in a director-level role overseeing a CAP/CLIA-certified laboratory.
  • Proven track record of successfully establishing or scaling a clinical lab.
  • Demonstrated expertise in molecular diagnostics for assay validation and verification.
  • Strong knowledge of laboratory quality systems, proficiency testing, and inspection readiness.
  • Experience with LIMS platforms, electronic quality management systems (eQMS), and workflow automation in a high-complexity testing environment.
  • Experience working for a fast-paced, growing organization

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