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 and implement new laboratory procedures and equipment following FDA and AABB (Advancement of Blood & Biotherapies) practices. Revise existing procedures, protocols, and forms to maintain a current and accurate procedure manual.•Customer Service: Provides excellent customer service to both external and internal customers. Responds to customer inquiries to address questions, issues, or concerns related to testing issues or requesting technical guidance. Ensures department provides quality customer services to all customers. Oversees production workflow to ensure department meets TAT requirements for internal and external clients.•Competency Assessments: Conducts CLIA and Non-CLIA competency assessments with appropriate follow-up and recommendations using the competency assessment process/tools.•Team Leadership: Provides oversight of testing laboratory operation and workflow, promoting efficient processes across all shifts. Fosters teamwork and communication within the team and with external partners. Engages in organizational activities, educational opportunities, and leadership training. Promotes and encourages participation in the employee recognition program and actively participates in department engagement initiatives. Promotes an engaged workforce through coaching, mentoring, and developing staff. Conducts regular staff meetings and weekly huddles. Promote and contribute to a culture of safety through compliance with all safety SOPs to include wearing proper personal protective equipment (PPE) i.e., safety goggles, gloves, lab coats, and proper shoes. Promptly report all safety violation observations and/or safety concerns.•Operational Management: Responsible for hiring new staff with the Laboratory Director and Supervisors. Approves PTO requests and performs payroll/timeclock functions. Coordinates communication during lab crises. Act as back-up to laboratory supervisors as needed. Assist in budget planning and long-term capital equipment needs. Oversee the Software Systems for laboratory processes. Ensure supervisors schedule staff to provide adequate coverage during hours of operation. Available during off hours by telephone as needed.•Staff Development: Positively mentors and educates supervisory staff on Donor Testing processes. Develop Performance Evaluation standards. Observe and communicate performance evaluations with staff throughout the year. Provide constructive feedback regularly. Conduct annual performance appraisals in a timely manner and with professionalism. Maintain performance documentation of staff. Conducts effective coaching and/or corrective action meetings for persisting issues or trends, as needed.•Inventory Management: Ensure supervisors provide inventory and order testing supplies in an efficient and cost-effective manner.

 

Secondary Functions:

•Additional Regulatory Compliance: Satisfactorily performs assigned proficiency testing in the same manner as donor samples and always follows Good Manufacturing Processes, with attention to detail. Successful completes annual competency assessment programs and annual organizational training. Assists with CAPA and root cause investigations. Participate in Continuing Education to meet national and state regulatory requirements and maintain records for staff and ensure good standing•Continuous Improvement: Keeps current on blood center issues and reads pertinent materials.•Research and Clinical Trials: Participates in ongoing investigational studies of reagagents, equipment, new methods, or clinical trials. Oversee training on protocol for clinical trials, maintain regulatory binders, and report findings to sponsor.•Change Management: Attends cross-departmental Change Management meetings when designated as project stakeholder, completes project deliverables by deadlines.•Tours and Student Rotations: Hosts in-person tours of the laboratory for visiting Residents and Fellows. Conducts virtual and in-person Infectious Disease Testing rotations for MLS/MLT/SBB students, Residents, and Fellows.

Qualifications

Required Minimum Education & Experience:

 

Education:Bachelor's degree in medical laboratory science (CLS/MLS/MT)OrBachelor of Science degree in chemical or biological science, with minimum requirement of 6 credits in biology and 6 credits in chemistry completed. or BA in core sciences (approval is dependent on transcript review). Must meet testing personnel requirements as described in the Clinical Laboratory Improvement Act of 1988 for Highly Complex Laboratory.

Related Experience:Minimum of four (4) years of clinical laboratory experience.

Supervisory experience is required.Any combination of education, training, and experience equivalent to the requirements above that has supplied the necessary knowledge, skills, and experience to perform the essential functions of the job.

 

Preferred Qualifications:

 

Education:Bachelor’s degree in medical laboratory science (CLS/MLS/MT).

 

Required Licenses/Certification:

National Clinical Laboratory Certification (ASCP or equivalent)

 

Required Knowledge, Skills & Abilities:

 

Knowledge:

•Knowledge of AABB, FDA, and OSHA regulations.•Working knowledge of Microsoft Suites.•Comprehend and apply clinical laboratory procedures and theory.•Working knowledge of LIS and BECS.•Working Knowledge of all institutional and personnel policies, confidentiality, and Good Manufacturing Practices (cGMP).

 

Skills:•Cultural competency and the ability to communicate effectively in a culturally sensitive manner with both individuals and groups from diverse backgrounds.•Written and oral communication skills and computer input/retrieval.•Attention to detail and organizational skills.•Accurate in transcription of numbers.•Decision making.•Demonstrate reliability and strong work ethic.

 

Abilities:•Resolve problems and customer concerns.•Maintain composure under pressure.•Work in a team environment or independently.•Work irregular hours or overtime as dictated by departmental needs.

 

Schedule: Full-time, Day shift

 

Proposed rate of Pay: $106,000 to $116,000.