Job Description
Job Description
Lighthouse Lab Services is partnering with a growing diagnostic laboratory near Chicago, IL to recruit a Lab Quality Manager. This critical role reports directly to the Director of Regulatory and Quality Affairs and is responsible for leading the laboratory's Quality Management Program in alignment with CLIA, CAP, NYS, and the companies quality standards.
This is an excellent opportunity for an experienced quality professional who thrives in a regulated, fast-paced clinical lab environment and is passionate about maintaining audit readiness, continuous improvement, and regulatory compliance.
Key Responsibilities:
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Ensure continued laboratory licensure and accreditation (CLIA, CAP, NYS) by managing renewals, new applications, test method submissions, and proficiency testing programs.
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Serve as the primary liaison between the lab and accrediting/regulatory agencies.
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Administer the lab's document control system, incident reporting, and personnel documentation processes.
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Review all laboratory SOPs and validation materials for regulatory compliance.
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Ensure staff qualifications align with regulatory requirements.
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Conduct internal quality audits across all lab sections and lead follow-up actions including CAPAs.
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Proactively identify compliance risks and recommend system improvements.
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Lead investigations and resolutions of non-conformances and deviations.
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Organize and lead quality system meetings; track and trend key performance indicators (KPIs).
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Train and support lab personnel in quality practices and regulatory standards.
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Manage audit response activities and ensure timely, well-documented resolutions.
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Provide regulatory and quality leadership across teams, staying current with evolving requirements.
Qualifications:
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Bachelor of Science in Medical Technology, Laboratory Sciences, or a related scientific discipline.
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Minimum 8 years of experience in a high-complexity CLIA-certified clinical laboratory.
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Deep understanding of regulatory standards (CLIA, CAP, NYS).
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Strong organizational, documentation, and written communication skills.
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Experience in quality systems, audit preparation, and cross-functional team leadership.
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Ability to assess risk and drive corrective/preventive actions.
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Excellent judgment, attention to detail, and collaboration skills in a regulated environment.
Salary and Benefits:
- Competitive salary
- Health, Vision, Dental
- PTO and Holidays
- Addt'l misc. benefits
Must be a US citizen or eligible to work in the US for any employer. No sponsorship will be provided.
About Us:
At Lighthouse Lab Services, we offer solutions to help start, grow, and run clinical laboratories. Our recruiting team has over 21 years of proven success placing job seekers in positions ranging from entry level Medical Technologists to seasoned Laboratory Directors. We recruit nationwide, for permanent and travel positions with clients ranging from small hospitals to large reference laboratories.
It is the policy of Lighthouse Lab Services to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. Lighthouse Lab Services is committed to working and providing reasonable accommodation to individuals of all abilities, including persons with disabilities. If at any time during the application process, you need an accommodation, please contact recruiting@lighthouselabservices.com for assistance.
Lighthouse Lab Services | 800-838-0602 | lighthouselabservices.com
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