Job Family:Operational Effectiveness
Travel Required:Up to 10%
Clearance Required:Ability to Obtain Public Trust
What 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 systems
- Support CLIA inspection readiness and remediation, including evaluating findings, assessing corrective actions, and engaging with CMS and surveyors
- Develop and maintain CLIA-aligned SOPs, policies, and compliance tools, ensuring effective documentation, version control, and audit readiness
- Implement regulatory requirements across equipment, personnel qualifications, workflows, and documentation systems
- Design and deliver targeted training programs addressing CLIA deficiencies and inspection risks, with clear learning objectives tied to remediation outcomes
- Develop training materials and competency frameworks and facilitate training for laboratory staff and stakeholders
- Apply expertise across pre-analytic, analytic, and post-analytic laboratory workflows to improve operational quality and compliance
- Support development and implementation of laboratory quality management systems, including personnel competency and reporting requirements
- Work effectively with cross-functional laboratory teams, supporting workforce development initiatives and training curricula
- Contribute to project workstreams and client deliverables, building strong relationships while delivering high-quality outputs
What You Will Need:- Bachelor's degree in Clinical Laboratory Science, Public Health, Biology, Chemistry, or related field
- 3-5+ years of experience in laboratory quality, compliance, and/or operations
- Demonstrated experience supporting laboratory requirements at the U.S. Centers for Disease Control and Prevention (CDC) or other federal health agency
- Experience with CLIA compliance and regulatory remediation
- Experience developing SOPs and quality documentation
- Expert knowledge of laboratory workflows
- Familiarity with quality management systems and accreditation
- Strong analytical, problem-solving, and communication skills
- Ability 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 organization
- Successful 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 bodies
- Experience applying laboratory expertise to the development of laboratory training curricula/programming
- Knowledge of College of American Pathologists (CAP) regulations
What 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 Insurance
- Personal and Family Sick Time & Company Paid Holidays
- Position may be eligible for a discretionary variable incentive bonus
- Parental Leave and Adoption Assistance
- 401(k) Retirement Plan
- Basic Life & Supplemental Life
- Health Savings Account, Dental/Vision & Dependent Care Flexible Spending Accounts
- Short-Term & Long-Term Disability
- Student Loan PayDown
- Tuition Reimbursement, Personal Development & Learning Opportunities
- Skills Development & Certifications
- Employee Referral Program
- Corporate Sponsored Events & Community Outreach
- Emergency Back-Up Childcare Program
- Mobility Stipend
