Job Description

Responsibilities

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 day-to-day supervision of personnel, operations, and workflow of the pre-analytical donor testing laboratory and donor testing inventory system. Responsible for the engagement of Laboratory Testing Assistant staff through proper personnel management, training, development, and evaluation.

This position also has general management responsibilities such as payroll approval, scheduling, inventory and ordering of supplies.

Supports and promotes organizational goals, mission, and vision. Contributes to a culture that aligns with organizational values.

Primary Duties & Responsibilities

• This position is responsible for oversight of pre-analytic procedures, donor testing laboratory inventory and maintaining records.
• Maintains competency in pre-analytical and donor testing support functions, follows cGMP, with attention to detail.
• Conduct and maintain In-House/Competency with direct observation/evaluation of laboratory testing assistant personnel.
• Promotes an engaged workforce through coaching, mentoring, and developing staff. Conducts regular staff meetings and weekly huddles.
• 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
• Responsible for hiring staff with the Laboratory Directory and Manager.
• Directs day-to-day operation and workflow, promoting efficient processes across all shifts. Manage processes to ensure efficient use of supplies and schedule staff to provide adequate coverage during hours of operation.
• Assist in training staff in new or revised procedures, equipment uses and maintenance procedures and processes.
• Assist in Maintaining training records of staff.
• Maintain donor testing laboratory inventory and order supplies in an efficient and cost-effective manner.
• Address staff errors and equipment failures.
• Conduct effective coaching and/or corrective action meetings for persisting issues or trends, as needed.
• Accessible to staff to provide on-site, telephone, or electronic consultation to resolve technical problems.
• Participates in ongoing investigational studies of equipment, new methods, or clinical trials.
• Troubleshoots equipment, schedules preventative maintenance, maintains a spare parts inventory. Utilizes service recovery responses when appropriate.
• Oversee laboratory inventory management processes for reagent receipt. Tasks include administrative oversight of the Inventory Management System.
• Assist with validation plans and execution as needed.
• Ensures department provides quality customer services to all customers. Monitors production workflow to ensure department meets TAT requirements for internal and external clients. Provides technical assistance to internal and external customers for laboratory related issues.
• Approves PTO requests and performs payroll/timeclock functions
• Acts as back-up for lab testing assistant related tasks

• Develop and implement new laboratory procedures and equipment following FDA (Food and Drug Administration) and AABB (Advancement of Blood and Biotherapies) practices.
• Revise existing procedures, protocols, and forms to maintain a current and accurate procedure manual.

Secondary Functions

• 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.
• Keeps current on blood center issues and reads pertinent materials
• Assists with CAPA and root cause investigations
• Work with Client Services and Donor Testing Supervisors to ensure testing is scheduled as needed.

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)

Skill:

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

Abilities:

• Resolve problems and customer concerns
• Maintain composure under pressure
• Work in a team environment or independently

Qualifications

Required Minimum Education & Experience:

Education: High School Diploma or GED

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

Preferred Qualifications:

Education: Associate degree or higher in related science field.

Experience: Lead or Supervisory experience

Schedule Full-Time; Day shift

Proposed annual salary range: $59,000. to $69,000.

Founded in 1979, 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. To learn more, visit ribc.org. Connect with us on Facebook, X, Instagram, and LinkedIn.