Manager, Testing Laboratories

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. Maintains 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.

Technical Competency

• Maintains competency as needed in donor testing functions and follows current Good Manufacturing Processes.
• 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.
• 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.

Operational Management

• Hires new staff with the Laboratory Director and Supervisors.
• Approves PTO requests and performs payroll/timeclock functions.
• Covers for laboratory supervisors as needed.
• Affords assistance in budget planning and long-term capital equipment needs.
• Oversees the Software Systems for laboratory processes.
• Ensures 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.

Required Minimum Education & Experience

• Education:
• Bachelor's degree in medical laboratory science (CLS/MLS/MT)
• Or Bachelor 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).
• Related Experience:
• Supervisory Experience Is Required.
• Minimum of four (4) years of clinical laboratory experience.

Preferred Qualifications

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

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.
• 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.

Pay

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

About the Organization

Rhode Island Blood Center (RIBC) has served Rhode Island and the New England area for more than 45 years, delivering more than 90,000 lifesaving blood products annually to 50+ hospitals, EMS and healthcare partners. RIBC is part of New York Blood Center Enterprises (NYBCe), which spans 17+ states and delivers one million blood products to 400+ U.S. hospitals annually. NYBCe additionally delivers cellular therapies, specialty pharmacy, and medical services to 200+ research, academic and biopharmaceutical organizations. NYBCe’s Lindsley F. Kimball Research Institute is a leader in hematology and transfusion medicine research, dedicated to the study, prevention, treatment and cure of bloodborne and blood-related diseases. RIBC serves as a vital community lifeline dedicated to helping patients and advancing global public health.