Job Type
Full-time
Description
OverviewWe 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.
- 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.
- CLSI Laboratory Quality Management System (LQMS) 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.
