Specialist, Quality Assurance

QUEST DIAGNOSTICS INC; Memphis (TN); On-site; USD 90,000 - 130,000; Full time

Job summary

Quest Diagnostics Inc in Memphis, TN, seeks an experienced QA professional to lead licensure, accreditation, and inspection activities across CAP, CLIA, GLS, ISO frameworks. The role coordinates internal and external QA efforts and ensures QMS compliance for all pre- through post-analytical processes.

The position focuses on proficiency testing, document control, internal audits, CAPA, and collaboration with Lab Managers and Quality Coordinators to sustain high quality standards in the local lab.

Qualifications

• Minimum of 2 years laboratory experience.
• Knowledge of CAP, CLIA, GLS, ISO standards and regulations.

Responsibilities

• Manage Proficiency Testing Programs (CAP and NYS); maintain data base and monthly summaries.
• Manage the Document Control System; support document control policies for procedures.
• Conduct Internal Audits to ensure inspection readiness and prepare reports.
• Facilitate preparation, distribution, and review of the QA Manual.
• Assist with external audits.
• Review protocols and recommend QA improvements.
• Coordinate compliance with regulations through documentation, audits and CAPA actions.
• Review quality records and investigate nonconformances with management.
• Audit training and competency programs.
• Review and approve non-conformances; ensure CAPA is implemented.
• Reportable Quality Issues and Revised Reports per SOP.
• Communicate with Lab Managers and QA staff to promote quality.
• Resource for CAP, CLIA, GLS, ISO regulatory inquiries.
• Monitor licensure and delegation per regulations.
• Ensure enrollment in external PT programs.
• Ensure APA program for tests not covered by PT.
• Compile data for QA indicators (RQI, PT outcomes, etc.).
• Review/write QA SOPs for department/lab services.
• Support compliance with company policies.
• Promote continuous quality improvement via standardization and process improvement.
• Perform special projects and other duties as assigned.

Skills

Leadership

Interpersonal skills

Communication

Detail orientation

Organization

Problem solving

Microsoft Office

Education

Bachelor’s Degree in Life Science

ASCP Certification (Preferred)

ASQ Certified Quality Auditor (Preferred)

Tools

Laboratory Information Systems

SOPs

Job description

Job Description

This position contributes to the overall QA Program of the laboratory. Responsible for licensure, accreditation and inspection of the laboratory. Accountable for the internal and external quality assurance programs. Position coordinates efforts that promote quality and ensures that all pre-analytical, analytical, and post-analytical processes within the QMS are compliant with CAP, CLIA, GLS, ISO and all other applicable regulatory or certification bodies. Functions as the representative for the Quality Assurance department to both internal and external functions.

This is a 5 day/Onsite position.

No relocation assistance available.

Responsibilities

• Manage Proficiency Testing Program (CAP and NYS) for the laboratory - maintain data base and produce monthly summaries.
• Manage the Document Control System. Support compliance with document control policies for all procedures and related documents.
• Conduct Internal Audits to ensure laboratory is inspection ready at all time and prepare corresponding report.
• Facilitates preparation, distribution, and review of the QA Manual.
• Assist with external audits.
• Review protocols and make recommendations to enhance QA Program.
• Coordinate compliance with applicable regulations through documentation, audits, and corrective action.
• Perform reviews of departmental quality records. Collaborate with management in the testing department to investigateand resolve nonconformances.
• Audit training and competency program.
• Assists to review and approve non-conformances and follows up with nonconformance owner to ensure that corrective actions and preventive actions (CAPA) are implemented and sustained.
• Assist in the prompt and complete reporting of Reportable Quality Issues and Revised and Amended Reports in compliance with the SOP.
• Effectively communicates with Lab Managers, Supervisors, and Quality Coordinators to ensure that employees consistently exhibit behavior that promotes and supports quality of the local business unit and Quest Diagnostic Lab.
• Functions as a resource for laboratory inquiries regarding CAP, CLIA, GLS, ISO and all other applicable regulatory or certification bodies.
• Monitors and reviews Testing Personnel have appropriate licensure, accreditation, and all duties are appropriately delegated as required by applicable federal, state, and local regulations.
• Ensure laboratory enrollment in external Proficiency Testing (PT) programs as required by Quest Diagnostics and regulatory agencies.
• Ensure Alternative Performance Assessment (APA) program is performed on tests that are not covered by external PT programs.
• Assists in compiling data and/or records to create Quality Assurance specific quality indicators, examples include but are not limited to Reportable Quality Issues (RQI), Proficiency Testing outcomes, Revised Reports tracking, and performance of internal and external inspections.
• Reviews or writes General Standard Operating Procedures for the Quality Assurance department or laboratory services.
• Actively supports and complies with all company policies and procedures.
• Promote continuous quality improvement by collaborating with management to implement standardization and process improvement.
• Perform special projects as assigned.
• Perform other duties as assigned to meet the business needs or customerrequirements. This is not an exhaustive list of all duties and responsibilities, but rather a general description of work performed by the position.

Qualifications

Required Work Experience:

• Minimum of 2 Years laboratory experience.

Preferred Work Experience:

• Previous experience with Quality Assurance.

Physical and Mental Requirements:

• The normal performance of duties may require lifting and carrying objects: Objects 1 to 10 pounds are lifted and carried frequently; objects 11 to 25 pounds are lifted and carried occasionally; objects 36 to 50 pounds are seldom lifted or carried and objects over 50 pounds are not to be lifted or carried without assistance.
• Ability to sit or stand for long periods of time.

Knowledge:

• Knowledge of CAP, CLIA, GLP and ISO standards and regulations.
• Basic theoretical and operational job knowledge in quality assurance and laboratory operations.
• Knowledge of organizational/departmental policies and procedures.
• Demonstrates knowledge of current company policies and procedures.
• Knowledge of CAP, CLIA, GLP and ISO standards and regulations.
• Demonstrates knowledge of current local, state, and federal requirements.
• Demonstrates initiative and strong problem-solving skills, teamwork, and interdepartmental collaboration.

Skills:

• Demonstrate leadership skills through accountability, integrity, and collaboration in daily tasks.
• Excellent interpersonal and communication skills (oral and written) necessary to effectively interact with all levels of staff.
• Project a positive, professionaldemeanor.
• Communicate with employees in a manner that creates an informed, positive environment.
• Facilitate efforts to work with others in a way that promotes teamwork and change.
• Must be detail-oriented, have the ability to work independently, establish work priorities and to handle several tasks simultaneously.
• Strong organizational and prioritization skills.
• Proven problem-solving skills with the ability to develop appropriate resolutions.
• Proficiency in Microsoft Office (Word, Excel and Outlook) and Laboratory Information Systems.

Education

• Bachelor’s Degree BA/BS Degree in a Life Science or equivalent combination of education and experience. (Required)

Licenses and Certifications

• ASCP Certification (Preferred)
• ASQ Certified Quality Auditor (CQA) (Preferred)

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Quest Diagnostics honors our service members and encourages veterans to apply.

While we appreciate and value our staffing partners, we do not accept unsolicited resumes from agencies. Quest will not be responsible for paying agency fees for any individual as to whom an agency has sent an unsolicited resume.

Equal Opportunity Employer: Race/Color/Sex/Sexual Orientation/Gender Identity/Religion/National Origin/Disability/Vets or any other legally protected status.