Position is directly responsible for coordinating and directing all functions of Quality Assurance and the CA CLS Limited License Training Program. This position assumes responsibility for ensuring that all technical and business requirements for laboratory testing are in place and maintained through the Quality Management System. This position sits as a member of the Nichols Leadership Team and is responsible for participating in all associated communication, planning and coordination activities. Reports to: Laboratory Director/regulatory; Managing Director-Operations/Business/Staffing.
- Regulatory (CMS, NYS, CA)
- Ensure compliance with federal and state laws and regulations concerning laboratory testing procedures and results.
- Oversees and manages operations for Quality Assurance, the Quality Improvement System, State Licensure, and the CA CLS Limited License Training Program.
- Manage the Quality Improvement System, which includes Corrective and Preventative Action (CAPA) and Annual Quality Improvement Plans.
- Direct internal and external audits related to ISO, CAP, State Laboratory Agencies and Clinical Trials. Responsible for preparedness, the audit process, and follow-up activities.
- Ensure an effective program of Document Control is in place. Business
- Coordinate and approve development of scorecard metrics and goals for Business Unit.
- Coordinate corporate quality and Customer directives with local procedures.
- Assure accurate and timely response to Customer Feedback and demonstrate continuous improvement to Customer Satisfaction Survey Scores.
- Ensure Training and competency requirements are defined and achieved at the Business Unit.
- Responsible for Business Unit's compliance to Clinical Trials Service Level Agreement.
- Identifies and relates the quality control, quality management requirements of Quest Diagnostics Inc. and the State, Federal and other agencies to department directors, managers, and supervisors to assure that these requirements are implemented and audited for compliance.
- Advises the appropriate supervisor, managers or technical director, if and when requirements are not met. Informs the Medical Director of such deviations.
- Advises the Medical Director regarding the quality status of the laboratory on a regularly scheduled basis.
- Manages off-site and in-house inspections, are required.
- Assembles and maintains procedures of Quality Assurance Department.
- Responsible for the selection, retention, training, evaluation and counseling of the Quality Assurance staff.
- Performs other related duties are requested by the Medical Director, and/or Managing Director.
- Bachelor's Degree required, General California Clinical Laboratory Scientist License or M. D. required.
- Advanced degree in Life Sciences and Business highly desirable.
- Demonstrated skills and training in Quality Improvement.
- Demonstrated written and oral communication skills. [All requirements are subject to possible modifications to reasonably accommodate individuals with disabilities. All duties and requirements are essential job functions.
- 10 years in a Clinical Laboratory setting.
- 5 years of demonstrated leadership and management responsibilities.
- 3-5 years’ experience in a Regulatory Environment or demonstrated knowledge in state and federal regulatory requirements. Special Requirements:
- Excellent communication skills, verbal and written.
- Ability to work without direct supervision.