TECHNICAL OPERATIONS CELLULAR THERAPY ANALYST (OKLAHOMA CITY, OK)

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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:

The primary objective of this position is to work with OBI Cellular Therapy Section to ensure accreditation compliance, operational effectiveness and efficiencies are maintained through vigilant development of SOPs, study protocols and process analysis. Support the implementation of project tasks and clinical research projects.

Qualifications:

• Bachelor's degree (or two year degree with reasonable experience) in related field
• Job experience in a blood bank, hospital or manufacturing Quality department
• Excellent writing skills
• Ability to maintain a positive and professional relationship with all individuals on the team and others throughout the organization.
• Ability to meet reporting deadlines
• Ability to effectively communicate in one-on-one situations and group situations
• Highly collaborative work style
• 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, verify, and collaborate on SOPS, forms, Verification and validation plans using quality tools and applicable regulations and standards (apheresis, cell therapy (CT) collections, CT lab, and Employee Health).
• Works with department managers and medical to ensure SOPs, workflows and tasks needed to support quality initiatives are implemented in a timely fashion and compliant.
• Tracks key milestones, tasks, and project interdependencies with Analyst.
• Provides regular communication of the status and progress of all projects assigned.
• Help laboratory technologists, nurses and others develop SOPs, perform Verification and Validation and ensure training is performed.
• Works with internal and external auditors and accreditation agencies to clarify expectations, nature of findings and remediation.
• Validate data integrity of submitted validation and verification reports.
• Provide various reports to the Cell Therapy sections as requested.
• With other Analyst, works to prioritize and manage multiple tasks to meet 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.

Salary : $1,000 - $5,000