Manager, Testing Laboratories

Manager, Testing Laboratories

Job Location s: US-RI-Providence

• :
• Category:
  Management
• Type:
  Regular Full-Time

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
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This position supervises assigned Testing Laboratory Supervisors and/or Specialists. Others as assigned.

Supervision of Positions
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Under general supervision of Director, Testing Laboratories.

• 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
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  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
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  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
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  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. Presents requested laboratory documentation to the inspecting agencies.
• Validations
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  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
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  Develop and implement new laboratory procedures and equipment following FDA and AABB practices. Revise existing procedures, protocols, and forms to maintain a current and accurate procedure manual.
• Customer Service
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  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
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  Conducts CLIA and Non‑CLIA competency assessments with appropriate follow‑up and recommendations using the competency assessment process/tools.
• Team Leadership
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  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…