Lab QMS Project Manager

Overview

Tanaq Management Services (TMS) delivers professional scientific and technical services and information technology (IT) solutions to federal agencies in the health agriculture technology and other government services. TMS is a subsidiary of the St. George Tanaq Corporation an Alaskan Native Corporation (ANC) committed to serving Federal customers while also giving back to the Tanaq native community and shareholders.

About the Role

We are seeking an experienced Lab Quality Management Specialist (QMS) Project Manager to join our team in support of a public health project for our Federal Government customer. The Lab QMS Project Manager will provide project leadership coordination and oversight for laboratory quality management activities that support the implementation maintenance monitoring and continuous improvement of laboratory quality systems.

The successful candidate will combine strong project management discipline with laboratory quality management experience. This role involves coordinating project plans schedules risks deliverables stakeholder communications quality metrics audit readiness activities CAPA tracking validation/verification documentation training coordination document control and continuous improvement initiatives. The LQMS Project Manager works closely with laboratory leadership quality managers scientists safety professionals regulatory stakeholders and clients to support compliant reliable and efficient laboratory operations.

This is a hybrid remote position that will require some onsite work in Atlanta Georgia.

Responsibilities

• Project Management and Delivery: Develop and maintain project plans schedules milestones risk registers action item trackers status reports and deliverable matrices for LQMS-related activities. Monitor project performance and ensure project deliverables and milestones are met.
• Stakeholder Coordination: Serve as a key coordinator among CDC laboratory leadership client representatives quality managers scientific staff safety personnel regulatory stakeholders vendors and contractor team members to align expectations resolve issues and maintain project momentum.
• Laboratory Quality Management System (LQMS) Support: Coordinate activities that support implementation maintenance monitoring and improvement of laboratory QMS/LQMS processes including quality plans SOPs quality records assessments management review inputs and quality objectives.
• Regulatory Compliance and Accreditation Readiness: Support compliance activities associated with applicable laboratory standards and requirements such as ISO 17025 ISO 15189 ISO 9001 CLIA CAP GLP FDA quality requirements CDC policies and other program-specific expectations.
• Audit and Assessment Management: Plan coordinate and track internal audits external assessments gap analyses inspection readiness activities audit evidence collection deficiency tracking and corrective action follow-up.
• Validation and Verification Coordination: Coordinate review and tracking of validation plans verification packages method performance documentation technical modifications validation summary reports reagent stability reviews and other laboratory quality deliverables.
• CAPA and Nonconformance Management: Track nonconforming events feedback complaints root cause analyses corrective actions preventive actions effectiveness checks and trend reports to support timely resolution and sustained process improvement.
• Document Control and Records Management: Coordinate SOP development document review cycles controlled document publication records retention eBinder management quality records training records and electronic document management activities.
• Quality Metrics and Reporting: Develop and maintain quality indicators dashboards audit findings trackers CAPA trackers validation status trackers project performance metrics and executive-level reports for laboratory leadership and client stakeholders.
• Training and Competency Tracking: Support development scheduling tracking and reporting of laboratory quality training competency assessments onboarding resources job aids and role-based training requirements.
• Risk Management and Continuous Improvement: Identify project risks dependencies resource constraints process gaps and recurring quality concerns. Recommend mitigation strategies and support continuous improvement initiatives that improve laboratory efficiency compliance data integrity and operational reliability.

Required Skills and Experience

• 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 applicable standards and frameworks such as 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 as required for the work environment.
• 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.

Education and Training

• Bachelors 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.
• Project Management Professional (PMP) Certified Associate in Project Management (CAPM) Lean Six Sigma ASQ Certified Quality Auditor (CQA) ASQ Certified Manager of Quality/Organizational Excellence (CMQ/OE) ISO 9001 or ISO 17025 auditor training CLSI Laboratory Quality Management System certificate or equivalent certification is preferred.
• Medical Technologist Medical Laboratory Scientist ASCP AMT AAB or equivalent laboratory certification is a plus when applicable to the laboratory environment.
• Biosafety Level 2 (BSL-2) training preferred; BSL-3 training is desirable when applicable to the assigned laboratory environment.
• Tier 1 select agent clearance is preferred when applicable to assigned work.

Physical Requirements

• 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 Personal Protective Equipment (PPE) to protect against exposure to pathogens and chemicals depending on laboratory access requirements.
• Ability to obtain necessary immunizations including Hepatitis B MMR Tdap/Tetanus IPV/Polio (as applicable) and Meningococcal among others as required for the work environment.

Who We Are

Tanaq Management Services (TMS) is a public health contractor certified 8(a) business owned by St. George Tanaq Corporation an Alaska Native Corporation. (ANC). We listen to our stakeholders and leverage our science technology communication and program expertise to understand and provide feedback as we develop solutions.

Our Commitment to Non-Discrimination

Tanaq is an Equal Employment Opportunity Employer. All qualified applicants will receive consideration for employment without regard to disability status as a protected veteran or any other status protected by applicable federal state or local law. Tanaq complies with the Drug-free Workplace Act of 1988 and E-Verify.

If you are an individual with a disability and need assistance completing any part of the application process please email to request a reasonable accommodation. This email is for accommodation requests only and cannot be used to inquire about the status of applications.

Notice on Candidate AI Usage

Tanaq is committed to ensuring a fair and competitive interview process for all candidates based on their experience skills and education. To ensure the integrity of the interview process the use of artificial intelligence (AI) tools to generate or assist with responses during phone in person and virtual interviews is not allowed. However candidates who require a reasonable accommodation that may involve AI are required to contact us prior to their interview at

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