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Salaried Clia Inspector Jobs (NOW HIRING)

Systimmune

Quality Assurance Manager

Redmond, WA · On-site

$120K - $160K/yr

  • Medical

  • Dental

  • Vision

  • Retirement

  • PTO

Lead internal audits and inspection readiness for CLIA/CAP and external audits * Manage CAPA ... The expected base salary range for this position is $120,000 - $160,000 annually. Actual ...

Rythm Health

Laboratory Compliance Specialist

Omaha, NE · On-site

  • Medical

  • Retirement

  • PTO

... CLIA, CAP, and New York State CLEP inspections and ensure that laboratory policies, records ... Highly competitive base salary. * Flexible, remote-friendly work environment. * Meaningful work ...

Rythm Health

Laboratory Compliance Specialist

Omaha, NE · On-site

  • Medical

  • Retirement

  • PTO

... CLIA, CAP, and New York State CLEP inspections and ensure that laboratory policies, records ... Highly competitive base salary. * Flexible, remote-friendly work environment. * Meaningful work ...

Ellipse Diagnostics

Laboratory Supervisor Florida

Palm City, FL · On-site

$70K - $90K/yr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

Competitive salary * Dental insurance * Health insurance * Paid time off * Vision insurance ... of laboratory inspections performed by CLIA/COLA and assist with any deficiencies for full ...

Frontage Laboratories

Histology Technician

Exton, PA · On-site

  • Medical

  • Dental

  • Life

  • Retirement

... CLIA, CAP and other applicable regulatory requirements, and help foster audit and inspection ... Salary and Benefits: Frontage Laboratories offer a competitive compensation and benefits package ...

Frontage Laboratories

Histology Technician

Exton, PA · On-site

  • Medical

  • Dental

  • Life

  • Retirement

... CLIA, CAP and other applicable regulatory requirements, and help foster audit and inspection ... Salary and Benefits: Frontage Laboratories offer a competitive compensation and benefits package ...

CareDx, Inc.

Quality Assurance Lead

Brisbane, CA

  • Medical

  • Retirement

  • PTO

Experience with FDA, CLIA, CAP, NY State audits and inspections preferred * Knowledgeable in ... Competitive base salary and incentive compensation * Health and welfare benefits, including a gym ...

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Salaried Clia Inspector information

What are some common challenges faced by salaried CLIA inspectors, and how can they be addressed?

Salaried CLIA Inspectors often encounter challenges such as staying up-to-date with evolving regulations, managing a diverse caseload of laboratories, and communicating complex compliance issues effectively. To address these challenges, inspectors typically engage in ongoing professional development, utilize standardized inspection checklists, and participate in regular team meetings to share best practices. Building strong working relationships with laboratory staff and fostering open communication also helps inspectors ensure a collaborative approach to maintaining regulatory compliance.

What skills and qualifications are needed to thrive as a salaried CLIA inspector?

To thrive as a Salaried CLIA Inspector, you need comprehensive knowledge of clinical laboratory practices, quality assurance standards, and regulatory compliance, typically backed by a degree in a life science or medical technology field. Familiarity with laboratory information systems (LIS), proficiency in audit tools, and CLIA-related certifications are often required. Strong analytical thinking, attention to detail, and effective communication skills help inspectors evaluate labs and convey findings clearly. These skills are vital to ensure laboratories meet federal standards, thereby protecting public health and ensuring accurate laboratory results.

What is the difference between Salaried Clia Inspector vs CLIA Laboratory Director?

AspectSalaried Clia InspectorCLIA Laboratory Director
CertificationsCLIA Inspector Certification, possibly state-specific licensesCLIA Certification, Laboratory Director Certification, and state licenses
Work EnvironmentRegulatory inspections, compliance assessments, on-site visitsLaboratory oversight, policy development, staff management
Employer & Industry UsageHealthcare facilities, laboratories, regulatory agenciesClinical laboratories, hospital labs, research institutions

While both roles require CLIA-related certifications, Salaried Clia Inspectors primarily conduct inspections and ensure compliance, whereas CLIA Laboratory Directors oversee laboratory operations, staff, and overall compliance. The roles differ in responsibilities, with Inspectors focusing on evaluation and Directors managing laboratory functions.

What is a salaried CLIA inspector?

Salaried CLIA Inspectors are professionals employed by regulatory agencies or organizations to assess and ensure that clinical laboratories comply with the Clinical Laboratory Improvement Amendments (CLIA) standards. Their responsibilities include conducting on-site inspections, reviewing laboratory procedures, and verifying that testing is performed accurately and safely. These inspectors play a critical role in maintaining public health by ensuring that laboratory results are reliable for patient care. Typically, they have backgrounds in laboratory science, healthcare, or regulatory compliance.
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Salaried Clia Inspector jobs near you
Infographic showing various Salaried Clia Inspector job openings in the United States as of August 2026, with employment types broken down into 95% Full Time, and 5% Part Time. Highlights an 95% Physical, 2% Hybrid, and 3% Remote job distribution.

Quality Assurance Manager

Systimmune

Redmond, WA • On-site

$120K - $160K/yr

Full-time

Medical, Dental, Vision, Retirement, PTO

Re-posted 7 days ago

Job description

SystImmune is a leading and well-funded clinical-stage biopharmaceutical company located in Redmond, WA and Princeton, NJ. It specializes in developing innovative cancer treatments using its established drug development platforms, focusing on bi-specific, multi-specific antibodies, and antibody-drug conjugates (ADCs). SystImmune has multiple assets in various stages of clinical trials for solid tumor and hematologic indications. Alongside ongoing clinical trials. SystImmune has a robust preclinical pipeline of potential cancer therapeutics in the discover and IND-enabling stages, representing cutting-edge biologics development. We offer an opportunity for you to learn and grow while making significant contributions to the company's success.
 
We are seeking an experienced Quality Assurance Manager to support our Translational Science department, which includes both Clinical Pathology and Bioanalytical functions. This role is responsible for ensuring compliance with Bioanalytical Lab QA (GLP/FDA) as well as CLIA/CAP requirements and partnering closely with scientific and laboratory teams to maintain a robust quality system supporting biomarker, IHC, and bioanalytical assay activities.
This is a senior individual contributor QA leadership role with no direct reports. This position is full-time onsite in Redmond, WA and will transition to our new Bothell, WA location in the fall.
Key Responsibilities
  • Maintain and improve the Quality Management System (QMS) in compliance with Bioanalytical Lab QA (GLP/FDA) and CLIA/CAP across Clinical Pathology and Bioanalytical labs
  • Develop, review, and approve SOPs, protocols, and quality documentation
  • Lead FDA inspection readiness and audits for bioanalytical laboratories, including preparation, hosting, and response management
  • Lead internal audits and inspection readiness for CLIA/CAP and external audits
  • Manage CAPA, deviations, change control, and document control systems
  • Ensure training compliance and documentation across both functional areas
  • Support assay validation, method transfer, and fit-for-purpose biomarker and bioanalytical workflows
  • Partner with translational scientists to ensure quality integration across Clinical Pathology and Bioanalytical operations
  • Track and report quality metrics and drive continuous improvement
  • Serve as QA representative during regulatory inspections and client interactions

Qualifications
  • Bachelor’s or Master’s degree in Life Sciences or related field
  • 7+ years of QA experience in bioanalytical (GLP/FDA) and/or CLIA/CAP laboratory environments
  • Strong knowledge of QMS processes (CAPA, deviation, change control, document control)
  • Experience supporting or leading FDA inspections for bioanalytical labs
  • Experience supporting laboratory audits and inspections
  • Familiarity with clinical pathology, bioanalytical, biomarker, or IHC-based workflows preferred
Preferred Qualifications
  • Experience in CDx, pathology/IHC, or bioanalytical labs
  • Knowledge of GxP environments (GLP/GCP/GMP)
  • Experience with LIMS and electronic QMS systems
  • ASQ certification (e.g., CQA) is a plus
Key Competencies
  • Strong understanding of bioanalytical QA and regulated lab environments
  • Hands-on experience with FDA inspection readiness and audit management
  • Ability to work cross-functionally with scientific and clinical teams
  • Detail-oriented with strong problem-solving and communication skills
Why Join Us
  • High-impact role supporting both Bioanalytical and Clinical Pathology functions within Translational Science
  • Opportunity to lead FDA inspection readiness and regulatory excellence
  • Collaborative, science-driven environment
 
Compensation and Benefits:
The expected base salary range for this position is $120,000 - $160,000 annually. Actual compensation will be based on a variety of factors, including but not limited to a candidate’s level qualifications, experience, and skills.
While most offers typically fall within the low to mid-point of the range, we may extend an offer toward the higher end for exceptional candidates whose background and expertise exceeds the requirements of the role.
 
SystImmune is a leading and well-funded biotech company with a bright future. We offer an opportunity for you to learn and grow while making significant contributions to the company’s success. SystImmune offers a comprehensive benefits package including: 100% paid employee premiums for medical/dental/vision, also STD, LTD, a 401(k) plan with a 50% company match of up to 3% and a vesting schedule of only 5 years, 15 PTO days per year, sick leave, plus 11 paid holidays and MORE.
 
We offer an opportunity for you to learn and grow while making significant contributions to the company’s success.
 
SystImmune is an Equal Opportunity Employer. We welcome diverse talent and encourage all qualified applicants to apply.

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