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 ISO 15189 and various State Licensure requirements and all other applicable regulatory or certification bodies. Functions as the representative for the Quality Assurance department to both internal and external functions.

• Primary responsibility is to ensure all State Licensure for NY CA PA RI Maryland and others as applicable are maintained in good order. Renewal of annual licenses manage CAP database and ensure information is current and reviewed periodically. Managing and facilitate submission of assays permits and categories for NYS
• Familiarity and provided guidance for various State requirements and standards.
• Facilitate and co-ordinate NYS onsite inspection with the laboratory and assist with inspection readiness .
• Conduct Internal Audits to ensure laboratory is inspection ready at all time and prepare corresponding report.
• Facilitate and manage State reportable program for various Tests and work closely with other laboratories and Quality & Regulatory team.
• Manage Cancer Registry Program and work closely with SMEs and Quality & Regulatory Team.
• 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 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.
• 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 and participate in quality oriented 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.

Required Work Experience:

• Minimum of 4-5 Years Clinical 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

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

Licenses and Certifications

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