Laboratory Quality Specialist III

Tanaq Management Services LLC•Atlanta, GA

4d•Hybrid

About The Position

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.

Requirements

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.
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.
Bachelor’s degree in Biology, Microbiology, Life Sciences or related field required.
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.

Nice To Haves

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.
Power BI and dashboards experience preferred.

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.