Laboratory Quality Specialist III

Tanaq Health; Atlanta (GA); Hybrid; USD 90,000 - 120,000; Full time

Job summary

Tanaq Management Services (TMS) seeks a Laboratory Quality Specialist III to join our team supporting a Lab QMS project for a Federal Government client. The role blends management, scientific, and regulatory duties to develop, monitor, and maintain the quality management system.

This hybrid role requires some onsite work in Atlanta, GA, with opportunities to coordinate accreditation activities and partner with client quality managers on risk and CAPA initiatives.

Qualifications

• Minimum 5 years of laboratory QA/QC in a cGMP environment.
• Experience with quality management, audits, CAPA, and CLIA compliance.
• Prior exposure to BSL-3 program and high containment practices.
• Experience with QMS and audit preparation.
• Power BI and dashboards experience preferred.
• Able to obtain immunizations and government clearance.
• Authorized to work in the United States without sponsorship.

Responsibilities

• Develop, implement, and annually assess the laboratory QA program.
• Review QA data and provide reports with trends to management and clients.
• Document control officer for lab procedures and policies.
• Coordinate CDC POC testing program activities and QC monitoring.
• Prepare policy reviews ensuring regulatory requirements are addressed.
• Coordinate activities for accreditation and government standards.
• Oversee equipment maintenance and third-party contracts.
• Upload ELIMS with equipment and room links.
• Document non-conforming events; use NCE database for steps.
• Monitor temperature with data loggers; analyze deviations.
• Coordinate validation of new testing/instrumentation.
• Deliver committee meetings and educational programs.
• Serve as primary client quality contact; respond to risk inquiries.
• Assist with staffing across service line as needed.

Skills

Laboratory QA/QC

QMS experience

CAPA handling

Audit preparation

Power BI

Security clearance

Education

Bachelor's degree in Biology/Life Sciences

Master's degree preferred

Certified Medical Technologist/CSL

BSL-2 training

BSL-3 training desirable

LQMS/ASQ certificates (preferred)

SA clearance preferred

Tools

Power BI

Job description

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.

Description

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 a Laboratory Quality Specialist III to join our team in support of a Lab QMS project for our Federal Government customer. The successful candidate will provide support involving a combination of management, scientific, and regulatory responsibilities. The Laboratory Quality Specialist III will develop, monitor, and maintain the quality management system for our client.

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

Responsibilities

• Assist with the development, implementation, and annual assessment of the laboratory Quality Assurance program.
• Review all laboratory quality occurrence data; provide reports to include specific monitors as defined by the Manager/Director, and graphical data to department management, clients, and customers.
• As the document control officer for Laboratory Services procedures, ensures annual review, and approves all policies.
• Coordinate CDC's point-of-care (POC) testing program activities, including equipment evaluation, policy development, and implementation/monitoring of quality control.
• Prepare, implement, and initiate laboratory policy and procedures review, conducting literature searches to ensure regulatory agency requirements are addressed and met.
• Coordinate department activities necessary for all accreditation and governmental agency standards.
• Manage equipment maintenance, documentation, cleaning, and decontamination for repair. Coordinates third-party vendor maintenance contract activities.
• Upload ELIMS with equipment and link to rooms.
• Document and complete non-conforming event steps, utilizing the NCE database.
• Monitor the daily temperature, using data loggers and liquid in glass thermometers. Download temperature deviations using the USB EasyLog Software.
• Coordinate the validation and implementation of new testing and instrumentation.
• Create and deliver formal and informal committee meeting presentations and educational programs. Direct meetings and discussions with coordinators and staff in developing strategy and action plans for programs/projects.
• Serve as primary point of contact with client quality managers. Analyze and respond to Risk Management inquires, unusual incident reports, and client concerns.
• Perform other duties as assigned, which include assisting with staffing needs across the service line as competencies allow.

Requirements

Required Skills and Experience

• Minimum 5 years of laboratory experience in laboratory QA/QC methods, preferably in a Current Good Manufacturing (cGMP) environment.
• Training and/or working experience with quality management, quality assurance, quality audit, CAPA, LSRB, OLSS, and CLIA compliance.
• Prior experience supporting BSL-3 program and expert knowledge in high containment practices.
• Experience in triaging feedback, complaints, non-conforming events, CAPA, and/or document control systems ensuring compliance to established procedures.
• Experience with QMS and audit preparation experience.
• Power BI and dashboards experience preferred.
• Ability to obtain necessary immunizations, including but not limited to, Hepatitis B, 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

• Bachelor's degree in Biology, Microbiology, Life Sciences or related field required. Master's degree preferred.
• Certified Medical Technologist or Clinical Laboratory Scientist highly desired.
• CLSI Laboratory Quality Management System (LQMS) Certificate preferred, but not required.
• Quality auditor ASQ certificate preferred, but not required.
• Biosafety Level 2 (BSL-2) training; BSL-3 training is desirable.
• Tier 1 select agent (SA) clearance preferred.

Physical Requirements

• Prolonged periods of sitting at a desk and working on a computer. May need to lift 25 pounds occasionally.
• May work with hazardous materials and need to wear Personal Protective Equipment (PPE) to protect against exposure to pathogens and chemicals.
• Ability to obtain necessary immunizations, including but not limited to, Hepatitis B, 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 [e-mail] 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 [e-mail].