TECHNICAL OPERATIONS CELLULAR THERAPY ANALYST

Pay: Competitive pay based on education and/or experience plus evening and weekend shift differential and $500 bonus after 6 months and $1,000 bonus after 1 year! Benefits: Health, dental, vision, life insurance, long term disability, 401(k), paid-time off, $5,000 annual tuition reimbursement, holiday pay, uniform allowance, etc. Days: Monday through Friday Hours: 8:00 a.m. to 5:00 p.m. Position: Work with OBI Cellular Therapy, Apheresis, and Employee Health sections to ensure accreditation compliance, operational effectiveness, and efficiency through the development of SOPs, validation/verification documentation, and process improvement initiatives. This position requires strong technical writing skills, project coordination experience, and solid understanding of regulated clinical or laboratory operations. The individual will serve as a key resource for standardizing processes, supporting validation activities, and ensuring consistent documentation across multiple healthcare programs. Qualifications: Bachelor's degree (or two-year degree with reasonable experience) in related field Experience in a blood bank, hospital, Cellular Therapy, Apheresis, Employee Health, or regulated manufacturing Quality environment required. Experience with SOP writing, validation, and verification in a regulated healthcare or laboratory setting required. Ability to establish and maintain positive, professional working relationships across clinical, laboratory, and administrative teams throughout the organization. Familiar with Lean Management concepts. Proficient in Microsoft Word, Excel, PowerPoint, and Access; Strong computer skills. Proficient in Master Control, eProgesa, and other blood bank and apheresis applications use and reporting – preferred. Primary Responsibilities: Author, revise, verify, and collaborate on SOPs, forms, and validation/verification plans using quality tools and applicable regulatory and accreditation standards across Cellular Therapy, Apheresis, CT collections, CT laboratory operations, and Employee Health. Works with department managers and medical leadership to ensure SOPs, workflows and tasks needed to support quality initiatives are implemented accurately, efficiently, and in compliance with regulations. Lead and support validation and verification activities for new processes, equipment, and procedural changes across all supported areas. Provide regular updates on project progress to leadership and stakeholders. Support laboratory technologists, nurses, and staff in developing SOPs, performing validation/verification activities, and ensuring required training is completed and documented. Collaborate with internal and external auditors and accreditation agencies to clarify expectations, address findings, and support corrective actions. Review validation and verification reports to ensure data integrity, completeness, and compliance with standards. Provide reports and documentation support to Cellular Therapy, Apheresis, and Employee Health programs as needed. Work with other Analysts and team members to prioritize and manage multiple assignments and deadlines. Help implement Cellular Therapy related Clinical Trials, Cellular Therapy related Commercial products and Cellular Therapy related R&D products into current laboratories. Organize and perform validation/verification of new equipment or for equipment moves, new processes and other duties as assigned. When assigned, evaluates existing processes; recommends action plan(s) for change; follows through to ensure effective, sustainable change. Ensures Cellular Therapy related business goals are achieved in a timely manner. Strong understanding of quality systems and regulatory standards (FACT, AABB, FDA preferred). Strong technical writing and documentation skills, with the ability to produce clear, accurate, and compliant SOPs, validation plans, and reports. Strong communication skills, including the ability to effectively communicate in both one‑on‑one and group settings. Strong organizational skills with the ability to manage multiple priorities and consistently meet reporting deadlines. #J-18808-Ljbffr Our Blood Institute