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Lab QMS Project Manager
Tanaq Government Services, LLC. Provide project leadership, coordination, and oversight for laboratory quality management activities .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in laboratory quality management systems (QMS/LQMS), regulatory compliance, and project management within a scientific environment. Proficient in developing quality plans, managing audits, and ensuring adherence to laboratory standards such as ISO 17025 and CLIA.
Highest-signal resume keywords
Laboratory Quality Management Systems (QMS/LQMS)Regulatory Compliance (ISO 17025, ISO 15189, CLIA)Project Management (Dashboards, Risk Registers)Audit Processes and Inspection ReadinessStakeholder Management and Communication
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Laboratory Quality Management Systems (QMS/LQMS)Regulatory ComplianceProject ManagementAudit ProcessesCorrective Action Follow-UpQuality MetricsDocument ControlQuality Improvement ActivitiesRisk ManagementQuality Records
Soft Skills
Problem-SolvingAnalytical SkillsFacilitation SkillsWritten CommunicationVerbal Communication
Tools & Technologies
Microsoft OfficeTeamsSharePointExcel-Based TrackersPower BILIMSElectronic Document Management SystemsQuality Workflow Systems
Certifications & Qualifications
PMPCAPMLean Six SigmaASQ CQAASQ CMQ/OEISO 9001 Auditor TrainingISO 17025 Auditor TrainingCLSI LQMS CertificateMedical Technologist CertificationMedical Laboratory Scientist Certification
Industry Keywords
ISO 17025ISO 15189ISO 9001CLIACAPGLPFDA Quality RequirementsCDC Laboratory PoliciesQuality Management ReviewBSL-2 Training
Tech Stack
Tools & technologiesPMP
About the role
Key responsibilities & impact- Provide project leadership, coordination, and oversight for laboratory quality management activities
- Develop and maintain project plans, schedules, milestones, risk registers, action item trackers, status reports, and deliverable matrices
- Monitor project performance and ensure deliverables and milestones are met
- Coordinate CDC laboratory leadership, client representatives, quality managers, scientific staff, safety personnel, regulatory stakeholders, vendors, and contractor team members
- Support implementation, maintenance, monitoring, and improvement of laboratory QMS/LQMS processes
- Coordinate quality plans, SOPs, quality records, assessments, management review inputs, and quality objectives
- Support compliance with laboratory standards and requirements including ISO 17025, ISO 15189, ISO 9001, CLIA, CAP, GLP, FDA quality requirements, CDC policies, and program-specific expectations
- Plan, coordinate, and track internal audits, external assessments, gap analyses, inspection readiness, audit evidence collection, deficiency tracking, and corrective action follow-up
- Coordinate validation plans, verification packages, method performance documentation, technical modifications, validation summary reports, and reagent stability reviews
- Track nonconforming events, complaints, root cause analyses, corrective and preventive actions, effectiveness checks, and trend reports
- Coordinate SOP development, document review cycles, controlled document publication, records retention, eBinder management, quality records, training records, and electronic document management
- Develop and maintain quality indicators, dashboards, audit findings trackers, CAPA trackers, validation status trackers, project performance metrics, and executive-level reports
- Support laboratory quality training, competency assessments, onboarding resources, job aids, and role-based training requirements
- Identify project risks, dependencies, resource constraints, process gaps, and recurring quality concerns; recommend mitigation strategies and support continuous improvement
Requirements
What you’ll need- Minimum of five (5) years of experience supporting laboratory operations, laboratory quality management, regulatory compliance, or laboratory project management
- Demonstrated experience managing multiple workstreams, deliverables, stakeholders, and deadlines in a regulated laboratory or scientific environment
- Strong knowledge of laboratory QMS/LQMS principles, quality systems, quality records, audit readiness, CAPA, document control, training records, equipment records, and quality metrics
- Working knowledge of ISO 17025, ISO 15189, ISO 9001, CLIA, CAP, GLP, FDA quality requirements, CLSI guidance, and CDC laboratory policies
- Experience with audit processes, regulatory compliance, gap assessments, inspection readiness, corrective action follow-up, and quality improvement activities
- Experience developing project trackers, dashboards, executive reports, quality management review inputs, audit reports, risk registers, and corrective action status updates
- Excellent problem-solving, analytical, facilitation, written communication, verbal communication, and stakeholder management skills
- Ability to translate laboratory quality requirements into actionable project plans and coordinate cross-functional teams to successful completion
- Proficiency with Microsoft Office, Teams, SharePoint, Excel-based trackers, Power BI or dashboard tools, LIMS, electronic document management systems, and quality workflow systems preferred
- Superior customer interface skills with emphasis on client communications, timely follow-up, documentation accuracy, and professional collaboration
- Ability to obtain necessary immunizations, including Hepatitis B, MMR, Tdap/Tetanus, IPV/Polio (as applicable), and Meningococcal, among others
- Ability to obtain government clearance
- Must be legally authorized to work in the United States without the need for employer sponsorship, now or at any time in the future
- Bachelor’s degree in Medical Laboratory Science, Biology, Microbiology, Chemistry, Biochemistry, Public Health, Quality Management, Project Management, or a related scientific discipline
- Advanced degree or formal training in laboratory quality management, regulatory science, or project management is preferred
- Preferred certifications/training include PMP, CAPM, Lean Six Sigma, ASQ CQA, ASQ CMQ/OE, ISO 9001 or ISO 17025 auditor training, CLSI LQMS certificate, or equivalent certification
- Medical Technologist, Medical Laboratory Scientist, ASCP, AMT, AAB, or equivalent laboratory certification is a plus when applicable
- BSL-2 training preferred; BSL-3 training desirable when applicable
- Tier 1 select agent clearance preferred when applicable
- Prolonged periods of sitting at a desk and working on a computer
- May need to lift up to 25 pounds regularly
- May be exposed to hazardous materials and may need to wear PPE
Benefits
Comp & perks- Full-time employment
- Hybrid remote work arrangement
- Equal Employment Opportunity protections
- Reasonable accommodation for applicants with disabilities
- Drug-free workplace
- Employer participation in E-Verify