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Laboratory Quality and Compliance Senior Associate

Guidehouse

Job Family:Operational EffectivenessTravel Required:Up to 10%Clearance Required:Ability to Obtain Public TrustWhat You Will Do:Guidehouse is seeking a Laboratory Quality and Compliance Senior Associate to support federal and public health laboratory clients in strengthening regulatory compliance, operational quality, and workforce capability.In this role, you will contribute to Clinical Laboratory Improvement Amendments (CLIA) compliance, laboratory quality systems, workforce training, and operational improvement initiatives. You will help clients implement training curricula that enhances laboratory competencies, resulting in improved abilities for laboratories to translate regulatory requirements into actionable processes and improve inspection readiness. Specifically, you will:Translate CLIA regulatory requirements into practical laboratory processes, policies, and workflows, ensuring compliance across personnel, testing, and quality systemsSupport CLIA inspection readiness and remediation, including evaluating findings, assessing corrective actions, and engaging with CMS and surveyorsDevelop and maintain CLIA-aligned SOPs, policies, and compliance tools, ensuring effective documentation, version control, and audit readinessImplement regulatory requirements across equipment, personnel qualifications, workflows, and documentation systemsDesign and deliver targeted training programs addressing CLIA deficiencies and inspection risks, with clear learning objectives tied to remediation outcomesDevelop training materials and competency frameworks and facilitate training for laboratory staff and stakeholdersApply expertise across pre-analytic, analytic, and post-analytic laboratory workflows to improve operational quality and complianceSupport development and implementation of laboratory quality management systems, including personnel competency and reporting requirementsWork effectively with cross-functional laboratory teams, supporting workforce development initiatives and training curriculaContribute to project workstreams and client deliverables, building strong relationships while delivering high-quality outputsWhat You Will Need:Bachelor’s degree in Clinical Laboratory Science, Public Health, Biology, Chemistry, or related field3–5+ years of experience in laboratory quality, compliance, and/or operationsDemonstrated experience supporting laboratory requirements at the U.S. Centers for Disease Control and Prevention (CDC) or other federal health agencyExperience with CLIA compliance and regulatory remediationExperience developing SOPs and quality documentationExpert knowledge of laboratory workflowsFamiliarity with quality management systems and accreditationStrong analytical, problem-solving, and communication skillsAbility to obtain a Public Trust clearance (i.e. US citizenship required)What Would Be Nice To Have:Relevant certification (e.g., CLS, MT) issued by ASCP or similar organizationSuccessful completion of a Medical Laboratory Scientist/Clinical Laboratory Scientist program accredited by the National Accrediting Agency for Clinical Laboratory Sciences (NAACLS) or an accrediting body recognized by the U.S. Department of Education at the time the degree was obtained.Experience working with CMS, CLIA surveyors, and/or accreditation bodiesExperience applying laboratory expertise to the development of laboratory training curricula/programmingKnowledge of College of American Pathologists (CAP) regulationsWhat We Offer:Guidehouse offers a comprehensive, total rewards package that includes competitive compensation and a flexible benefits package that reflects our commitment to creating a diverse and supportive workplace.Benefits include:Medical, Rx, Dental & Vision InsurancePersonal and Family Sick Time & Company Paid HolidaysPosition may be eligible for a discretionary variable incentive bonusParental Leave and Adoption Assistance401(k) Retirement PlanBasic Life & Supplemental LifeHealth Savings Account, Dental/Vision & Dependent Care Flexible Spending AccountsShort-Term & Long-Term DisabilityStudent Loan PayDownTuition Reimbursement, Personal Development & Learning OpportunitiesSkills Development & CertificationsEmployee Referral ProgramCorporate Sponsored Events & Community OutreachEmergency Back-Up Childcare ProgramMobility StipendAbout GuidehouseGuidehouse is an Equal Opportunity Employer–Protected Veterans, Individuals with Disabilities or any other basis protected by law, ordinance, or regulation.Guidehouse will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of applicable law or ordinance including the Fair Chance Ordinance of Los Angeles and San Francisco.If you have visited our website for information about employment opportunities, or to apply for a position, and you require an accommodation, please contact Guidehouse Recruiting at View phone number on click.appcast.io or via email at View email address on click.appcast.io. All information you provide will be kept confidential and will be used only to the extent required to provide needed reasonable accommodation.All communication regarding recruitment for a Guidehouse position will be sent from Guidehouse email domains including @guidehouse.com or View email address on click.appcast.io. Correspondence received by an applicant from any other domain should be considered unauthorized and will not be honored by Guidehouse. Note that Guidehouse will never charge a fee or require a money transfer at any stage of the recruitment process and does not collect fees from educational institutions for participation in a recruitment event. Never provide your banking information to a third party purporting to need that information to proceed in the hiring process.If any person or organization demands money related to a job opportunity with Guidehouse, please report the matter to Guidehouse’s Ethics Hotline. If you want to check the validity of correspondence you have received, please contact View email address on click.appcast.io. Guidehouse is not responsible for losses incurred (monetary or otherwise) from an applicant’s dealings with unauthorized third parties.Guidehouse does not accept unsolicited resumes through or from search firms or staffing agencies. All unsolicited resumes will be considered the property of Guidehouse and Guidehouse will not be obligated to pay a placement fee. #J-18808-Ljbffr

Vacancy posted 1 day ago
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