Specialist, Quality Assurance

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. 

• 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 investigate and 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 customer requirements. This is not an exhaustive list of all duties and responsibilities, but rather a general description of work performed by the position.

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, professional demeanor. 
• 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)