WHAT YOU WILL BE DOING:
The Director of Quality will provide leadership and direction to the quality operations team overseeing clinical laboratory testing, the quality system of the laboratory and study execution. Responsible for activities related to Quality Department financial management, productivity, strategic planning, continuous improvement, staff development and management, procedures, and developing and implementing new services. Completes special assignments as assigned by the laboratory management team. Responsible for ensuring that the laboratory meets quality and productivity standards and complies with all regulatory and safety standards as defined by CAP, JCAHO, CLIA, NYDOH, CA and OSHA.
Essential Responsibilities:

• Responsible for technical and quality oversight of laboratory operations and personnel performing pre-analytical, analytical, and post-analytical tasks as it relates to quality.
• Leadership role within the lab QA department that assists with planning, implementing, and monitoring the Quality Management System (QMS).
• Implements and supports Quality Assurance Program and regulatory compliance.
• Collaborate with Technical Supervisor and Laboratory Director for Quality Assurance updates, education, and updating/reviewing any CLIA regulations.
• Participates in internal/external audits (CAP).
• Ensure establishment and/or verification of laboratory test performance specifications and ensure they are maintained.
• Monitor quality metrics: ensuring that remedial actions are taken, ensuring that patient results are not reported until corrective actions are taken, and test systems are functioning properly and in compliance.
• Directs, coordinates, and oversees quality activities and projects to ensure that services are provided on schedule within quality and cost objectives.
• Acts on operational issues with urgency to stay up to date on regulatory and compliance needs of the laboratory.
• Provide trouble-shooting expertise for out-of-control systems or tests when not immediately resolvable by the technologist or supervisor.
• Direct implementation of possible process changes to improve quality, efficiency, and accuracy for the lab.
• Direct technologists in development of new methods through regular meetings and provides requirements and protocols for assessing validation acceptability.
• Participates in technical development group efforts through interactive meetings and discussions that promote process improvements and technology developments.
• Oversees test implementation as per compliance and regulatory requirements.
• Monitors ongoing test performance (Review of QC, PT, patient means).
• Participate in selection of methodology and analytical techniques for performing clinical lab tests, taking into account accuracy, reliability, timeliness, cost, and technical difficulty.
• Creates development and training plans for supervisory and lab personnel within the laboratory.
• Assists with monitoring and responding to monthly volumes, utilization, financial, operational, and quality metrics as needed.
• Participate in long-term planning for lab equipment and review with upper management.
• Coordinates with IT and Supervisors to prioritize, validate and implement LIS changes to ensure accuracy of patient result reporting.
• Completes special assignments as assigned by the laboratory director or VP of lab operations.

OUR IDEAL CANDIDATE HAS:

• Education: Master's degree or PhD in Biological Sciences
• Experience: 8 years of related experience
  • In depth knowledge of complex laboratory techniques, laboratory safety and quality assurance to support ongoing and future projects.
  • Experience in statistical data analysis, creation and maintenance of policies and procedures, spreadsheets, chart and graphs, and data management.
  • Required: Must have experience with QuantStudio 12k, HoligicPanther system, Abbot Hologic and/or Thermo Fisher experience
  • Required: Experience working in a CAP/CLIA regulated laboratory with molecular testing
  • Required: Must have experience in foundational FDA510K/ISO.
  • PLUS: New York (NY) State accreditation in process or completed
• Knowledge/Skills:
  • Ability to travel up to 50%
  • Ability to effectively communicate with various level stakeholders.
  • Proficient in Microsoft Office Suite (Word, Power Point, Excel, etc.)

ABOUT OUR CLIENT:
MP's client is the nation's leading PCR-based infectious disease laboratory, advancing healthcare through decentralized patient-directed testing, large-scale surveillance pathogen testing, antimicrobial stewardship, and value-based care programs. In a global environment threatened by growing antimicrobial resistance, rapid diagnoses matter. MP's client sets the pace for industry-leading laboratory operations through unparalleled turnaround time, yielding insights that mobilize accurate clinical decisions. With over 20 years in the clinical laboratory industry, MP's client provides services to over 10,000 clinicians nationwide.
ADDITIONAL INFORMATION:

• Compensation Range: $125,000 - $155,000 per year (salary).
• Location: Clarksville, IN (5 minutes from Louisville, KY). Traveling to other labs required. Relocation assistance may be provided depending on level of experience and current location.
• Benefits: Medical, Dental, Vision, and more!
• Shift/Schedule: 9:00am - 5:00pm, Monday - Friday