Manager, Testing Laboratories

Responsibilities Position Summary : Responsible for the operation of their designated team in accordance with established Standard Operating Procedures (SOPs), applicable sections of the Code of Federal Regulations (CFRs), with emphasis on Good Manufacturing Practices (GMPs), the Clinical Laboratory Improvement Act of 1988 (CLIA), and applicable policies, procedures, and quality initiatives. Provides excellent customer service and maintains proactive client communications. Maintain strong relationships with internal and external customers through anticipation of their needs and problem resolution. Provides oversight of laboratory operations. Responsible for the engagement of Donor Testing supervisors through proper personnel management, training, development, and evaluation. This position also has general management responsibilities such as payroll approval, scheduling, and ordering supplies. Supports and promotes organizational goals, mission, and vision. Contributes to a culture that aligns with organizational values. Supervision Exercised: This position supervises assigned Testing Laboratory Supervisors and/or Specialists. Others as assigned. Supervision of Positions: Under general supervision of Director, Testing Laboratories. Primary Duties & Responsibilities : • Technical Competency : Maintains competency as needed in donor testing functions and follows current Good Manufacturing Processes.•This position performs only those tests that are authorized by the CLIA laboratory director and performs only those tests that require a degree of skill commensurate with the individual's education, training or experience, and technical abilities.•Acts as back-up for testing related tasks and paperwork review.• Critical Thinking and Problem Solving : Oversees investigations for problems encountered during routine lab operations ensuring all required troubleshooting is performed and documented, and preventative maintenance schedules and spare parts are maintained.• Error Management : Performs and documents investigations for department Deviations and Error Tracking. Collaborates with department leadership to create preventative and/or corrective actions to prevent reoccurring issues. Initiates adverse testing event procedures and product recalls for critical testing errors.• Quality Management : Performs secondary review of equipment out of service documentation. Ensures investigations are performed for reoccurring issues or trends. Ensures that preventative/corrective actions are taken when staff, equipment, or test systems are found to deviate from the laboratory's established performance specifications. Present requested laboratory documentation to the inspecting agencies.• Validations : Leads Change Management projects and participates in organizational initiatives. Assists in the development and execution of validations for department SOPs, lab equipment, test kits, and laboratory information systems.• Document Control : Develop…