Blood & Tissue Manufacturing Associate I (Full-time)

Pay Rate: Hourly $20.00-$23.00 /Annually $41,600.00-$47,840.00 Job Title: Blood & Tissue Manufacturing Associate I Revision: 0002 Job Code: 700236 Shift: Sunday-Thursday (4pm-12:30am) or Tuesday -Saturday (4pm-12:30am) FLSA: OT Eligible Hybrid? N Dept.: Components Business Unit: STB&T CPF Level: TB1 General Summary Responsible to inspect and perform all phases related to blood components production and labeling in accordance with all Standard Operating Procedures (SOPs), organizational policies, and regulatory and cGMP/cGTP requirements. Will prepare specialized blood components and quarantine blood components. Will also provide in‑ service training to staff regarding policies and Standard Operating Procedures (SOPs). Responsible for activities related to the aseptic processing of human cells and tissue, maintenance of surgical instruments and equipment, and proper documentation of all activities. Must be able to operate all major and minor processing equipment and maintain processing supplies and equipment inventory. Participate in the development of Standard Operating Procedures (SOPs) for the cell and tissue processing and distribution. Responsible to perform and assist in coordination of all operational aspects of the cord blood accessioning and processing areas. Ensures all laboratory procedures are conducted in compliance with prescribed regulations. Maintains all technical activities to include training and the performance of high complexity, routine laboratory procedures. Responsible to receive, accession, and distribute testing samples to Laboratory Services testing laboratories. Recognize unusual situations and resolve discrepancies. Communicate discrepancies to management. Maintain accurate records of incoming and outgoing samples. Commit to and abide by the character of BioBridge Global’s Core Values of Accountability, Stewardship, Pioneer, Integrity, Respect and Excellence (ASPIRE). Support, communicate and reinforce the mission and vision of the enterprise. Provide world class customer service by capturing and being responsive to the voice of the customer (internal or external, including donors for select positions) through multiple feedback channels in order to resolve issues and drive satisfaction in accordance with the BBG customer engagement, feedback, and complaint processes. Major Duties and Responsibilities Essential Tasks Process blood components to established quality standards. Follow Daily Production Plan to maintain adequate inventory of blood components. Accurately label blood components. Prepare specialized blood components as directed. Report on the final disposition of components. Verify Standard Operating Procedures (SOPs) as assigned. Quarantine blood components which are non‑conformant per SOP. Perform quality control, and maintenance on equipment and document appropriately. Assist senior technicians in maintaining adequate supply levels. Assist in staff training as required. Evaluate and document competency levels through direct observation and testing. Perform weekend on‑call duties on a rotating basis. Provide exceptional customer service internally and externally. Maintain good working relationship with co‑workers, senior technicians, other departments, and management. Report any irregularities, difficulties, and unusual results immediately. Assist in the developing of the cell and tissue processing procedures according to the AATB, FDA, and cGMP/cGTP standards. Utilize the aseptic techniques for processing of cells and tissue. Perform instruments and supplies sterilization procedures according to sterilization guidelines. Maintain processing instruments, supplies and equipment inventory, and ensure an adequate supply. Operate processing equipment and maintain maintenance and monitoring records such as: freezer, freeze dried and room temperature readings. Perform receiving, accessioning and distributing of testing samples to the laboratory as needed. Maintain accurate records of incoming and outgoing samples. Perform cell and tissue processing room disinfection procedures according to Clean Room and organizational guidelines. Perform processing, packaging and labeling of the cells and tissues according to procedures, AATB, cGMP and organizational standards. Maintain complete and accurate records of all steps in the cell or tissue product manufacturing process to assure product documentation and traceability. Perform all necessary quality control procedures and maintain complete records of results. Follow proper safety procedures. Performs other duties as assigned. Non‑Essential Tasks May have interaction with and/or exposure to various groups, VIPs, and/or media. Run departmental errands as directed. Education Requires sixty (60) hours or Associate Degree from an accredited technical/vocational institute, college or university. Licenses and/or Certifications Certified Medical Laboratory Technician (MLT) preferred Experience No prior specific work experience required. Prefer two or more years of laboratory experience, sterile technique, instruments and equipment sterilization techniques. Prefer one year of blood center experience. Knowledge Must have a working knowledge of component processing techniques. Must obtain a working knowledge of regulatory/quality requirements and perform within all Standard Operating Procedures (SOPs) and policies. Must have a working knowledge of equipment and procedures for various technologies. Skills Must be capable of inputting computer data with accuracy. Must have strong manual dexterity and technical abilities in the use of processing and testing equipment. Must be prepared to identify root causes of problems and select the best course of action when circumstances require. Must be capable of operating laboratory and/or other job‑related equipment. Must have strong computer skills. Must have excellent written and oral communication skills. Must be able to print and write legibly. Abilities Must be a self‑starter and self‑directed worker. Must be able to keep information confidential. Must be able to make good sound judgment decisions. Must be able to work with interruptions, meet deadlines, and perform accurate work and/or reports. Must be neat in appearance and well groomed. Must be professional, detail oriented, self‑motivated, innovative, creative, assertive, organized, communicative, and have the ability to work independently. Must have the ability to lead training programs in component procedures. Must perform well in repetitive work situations. #J-18808-Ljbffr BioBridge Global