Manager, Quality Assurance

Lead support and coordinate efforts that foster quality and ensure that all pre-analytical analytical and post-analytical processes are consistent with our company values and mission.

This is an Onsite position

Leadership

• Direct advocate for and enable visibility of quality processes. Ensure accountability within all areas of the business unit (pre-analytical analytical and post-analytical) such that every employee consistently exhibits behavior that promotes and supports quality. Influence may be exerted both directly and indirectly through the management of liaisons and intermediaries such as department supervisors and members of the Quality Assurance (QA) Committee.

Licensing and Accreditation

• Direct internal inspection process of the business unit associated laboratories and specimen collection sites to ensure compliance with applicable federal state and local regulations College of American Pathologists (CAP) accreditation requirements and Quest Diagnostics standards. Review and ensure that corrective action is implemented when non-conformances are found.
• Monitor published guidelines for revisions to regulations and/or accreditation standards and ensure laboratory compliance. Serve as a resource regarding Clinical Laboratory Improvement Amendments of 1988 (CLIA 88) regulations and CAP accreditation standards for all sites.
• Ensure all testing facilities/personnel have appropriate licensure and accreditation as deemed by federal state and local regulations. Collaborate with business unit management even if primary responsibility has not been assigned to QA.

Proficiency Testing

• Identify all tests performed and ensure enrollment and participation in external proficiency testing for each test. For those tests not covered by external proficiency testing ensure internal proficiency testing is performed. Ensure that all proficiency testing is reviewed and corrective action is complete for all non-conformances.
• Ensure that a Validity Check program is in place as well as a Blind Samples resubmission program if applicable.
• Ensure that a defined instrument to instrument method to method and laboratory to laboratory comparison process with fixed criteria for accessing acceptability is performed and documented at least semi-annually. Quality Assurance/Quality Improvement
• Conduct monthly QA meetings with required participation by all areas having an impact on pre-analytical analytical and post-analytical phases of testing (exception Billing). Create effective materials (e. g. graphs charts) to promote Quality Improvement (QI) and present plans and results at monthly meetings.
• Ensure that each department has a comprehensive Quality Improvement plan with monitors and that each department communicates their metrics and implements appropriate actions.
• Develop monitor and improve Quality Assurance specific quality indicators including but not limited to: Reportable Quality Issues Proficiency Testing outcomes Revised Reports tracking and performance on inspections.
• Prepare revise and distribute a QA Manual that includes local QA policies. Ensure all applicable employees are trained and comply with policies. Ensure all QA policies have annual review.
• Ensure a process is in place to resolve customer complaints regarding pre-analytical analytical and post- analytical issues.
• Ensure performance of required Corporate Quality Surveillance Program Patient Results Distribution Program Best Practice Team Initiative/Database Changes Verification Program and other monitoring programs specifically assigned by National Quality Assurance (NQA). Quality Control
• Act as a contact for national Quality Control (QC) peer comparison programs and ensure enrollment and effective corrective action as appropriate. Quality Assurance Initiatives
• Ensure all duties are appropriately delegated as required by applicable federal state and local regulations.
• Ensure that all departments have a process to identify and evaluate the relationship of patient information to patient test results. Ensure the process is in place up to date distributed and that all personnel are in compliance.
• Ensure prompt and complete reporting of Reportable Quality Issues in compliance with the Standard Operating Procedure (SOP) and ensure effective corrective action including issuance of revised reports as applicable.
• Ensure complete tracking of revised reports in compliance with the SOP and ensure effective corrective action.
• Ensure compliance with all NQA standards as required.

Required Work Experience:

Minimum 8 years of lab experience with at least 4 years of direct laboratory quality and regulatory agency experience.

Physical and Mental Requirements:

• Ability to sit or stand for long periods of time
• May be required to use a variety of manual and automated pipettes as well as a variety of laboratory instruments.
• 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 carried occasionally and objects 35-50 pounds are lifted or carried seldom.

Knowledge:

• Comprehensive theoretical and operational job knowledge in quality laboratory operations
• Knowledge of organizational & departmental policies and procedures

Skills:

• Proven problem-solving skills
• Detail-oriented with the ability to work independently or part of a team
• Interpersonal and communication skills necessary to deal courteously and effectively with employees co-workers and clients
• Ability to deal with client information in a confidential manner
• Proficiency in Microsoft Office and Laboratory Information Systems

Education

• Bachelors Degree in Medical Technology or another Heath Care Science degree
• Masters Degree Preferred