TECHNICAL OPERATIONS CELLULAR THERAPY ANALSYT

ADVANCE YOUR CAREER WHILE SAVING LIVES

Location: Oklahoma City, OK

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.