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.

This position is responsible for manufacturing and providing training and support in the manufacturing of blood products according to cGMP compliant policies and procedures. Ensures that all products meet the safety, purity, and potency requirements of the FDA, AABB and other regulatory agencies.

• Prepare and label products routinely according to Component Lab Standard Operating Procedures, including but not limited to red blood cell products, platelets, and plasma
• Performs visual inspection of blood products at each step of processing as the primary reviewer.
• Performs required equipment maintenance, trouble shooting and quality control on assigned instrumentation
• Identify and report problems that may adversely affect products, perform corrections, if applicable, quarantine when required.
• Obtain samples for quality control or requested testing from various products as assigned
• Perform testing on samples/products following departmental SOPs to meet standards of regulatory agencies
• Performs general laboratory cleaning, QC and maintenance
• Monitor inventory of laboratory supplies
• Quarantines products or supplies when
• Unpack, receive, and inspect shipments containing blood products and/or donor
• Respond to environmental and storage Perform corrective action when necessary
• Performs data entry into BECS and usage of applicable software
• Generates various reports
• Prepare specialty products as defined by department operating procedures
• Execute qualification, validation, and verification protocols
• Identify, investigate, troubleshoot and perform corrections, if applicable, and quarantine when required for all non-conforming products. Communicate all problems that may adversely affect products to appropriate supervisor/designee
• Manage holds on blood component products, as instructed
• Maintain sufficient reagent stock and other necessary department Notify appropriate supervisor/designee when levels are low.
• Recognizes and reports to superiors' problems encountered during performance of job tasks including equipment malfunction, deviation from standard operating procedure, unusual results, and discrepancy in test controls or controls outside established normal limits.
• Follows laboratory policies and procedures whenever test systems are not within the laboratory’s established performance specifications.
• Document all corrective actions taken when test systems deviate from the laboratory’s established performance specifications
• Perform competency assessments for non-CLIA activities
• Manage inventory of laboratory supplies and order as needed
• Investigate product holds and troubleshoot as needed
• Assist in reviewing manufacturing records, as
• Perform emergency product release
• Act as subject matter expert for laboratory equipment
• Makes recommendations to improve business unit practices and
• Collaborate on controlled document creation and

Lead Duties:

• Assigning tasks to staff
• Directs day to day
• Assign training tasks as needed to staff members.

Education:

High School Diploma or GED

Related Experience

Internal: Training and competency as Level III technician, must meet department requirements for promotion.

External: Three or more years of related laboratory or manufacturing experience or an associate's degree or higher in biological science with post graduate laboratory experience.

Preferred Qualifications:

• Education: Associate's degree in a field of biological science
• Experience: Component production or clinical laboratory Laboratory manufacturing experience using cGMP Customer service