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Laboratory Quality Specialist III
Tanaq Government Services, LLCLaboratory Quality Specialist III developing and maintaining quality management systems for Federal Government customer. Ensuring compliance and providing support in a hybrid remote capacity.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive experience in laboratory Quality Assurance and Quality Control (QA/QC) methods, with a strong focus on compliance with regulatory standards such as cGMP, CAPA, and CLIA. Capable of managing laboratory policies, coordinating accreditation activities, and effectively communicating with clients and stakeholders.
Highest-signal resume keywords
Laboratory Quality AssuranceQuality Management SystemsCAPA ImplementationBSL-3 Program SupportRegulatory Compliance
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Quality Assurance MethodsQuality Control ProceduresDocument Control SystemsTemperature MonitoringData Analysis
Soft Skills
Communication SkillsProblem-SolvingTeam CoordinationPresentation Skills
Tools & Technologies
USB EasyLog SoftwareNCE DatabaseData Loggers
Certifications & Qualifications
Hepatitis B ImmunizationGovernment Clearance
Industry Keywords
Current Good Manufacturing PracticesCLIA ComplianceHigh Containment PracticesAccreditation Standards
About the role
Key responsibilities & impact- 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, ensure annual review, and approve 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.
- Coordinate 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 inquiries, 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
What you’ll need- 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.
Benefits
Comp & perks- Health insurance
- Paid time off
- Flexible work arrangements
- Professional development opportunities