Process Improvement Analyst

OneBloodOrlando, FL
Onsite

About The Position

Provides process review, technical documentation, and validation support for Operations within a defined system. Collaborates with team members and SMEs to identify workflow issues, document processes, and support improvements through compliant procedures and structured testing. Must be based in or around the Greater Orlando area.

Requirements

  • Bachelor’s degree and 2 years of experience in related field.
  • Demonstrated proficiency in technical writing, process mapping, and computer applications required.

Nice To Haves

  • Prior experience in laboratory testing, blood products, biotherapies, or biologics manufacturing environments preferred.
  • Six Sigma (Green Belt, Black Belt, Master Black Belt), Lean, ISO 9001, or ASQ (American Society for Quality) credentials preferred
  • Exceptional knowledge of Biologics and Donor Services processes
  • Exceptional knowledge of blood banking regulations
  • Exceptional technical writing ability
  • Proficient computer skills including Microsoft Office applications
  • Ability to organize work for timely completion
  • Ability to follow complex oral and written instructions
  • Ability to speak, write, read and understand English
  • Ability to communicate effectively orally and in writing
  • Ability to establish and maintain effective and cooperative working relationships with those contacted in the course of work

Responsibilities

  • Contributes to system implementations and transitions, including migration from legacy platforms to new operational systems
  • Collaborates with SMEs to analyze current-state (“as-is”) workflows and design future-state (“to-be”) process maps and flowcharts, incorporating end-to-end donor flow and frontline operational workflows (e.g., phlebotomy processes)
  • Develops process flows to support product and process design and identify changes, gaps, and operational impacts
  • Creates and maintains technical documentation, including SOPs, validation test plans, technical specifications, data collection forms, and supporting reports
  • Assesses process and system changes to determine impact and define testing strategies and validation requirements
  • Designs and executes testing activities, including User Acceptance Testing (UAT) and validation, to ensure system functionality meets defined requirements
  • Performs revalidation of functional processes and ensures proper integration, organization, and traceability of validation documentation
  • Ensures blood manufacturing process systems are in compliance with regulatory agency requirements, company standards and current industry practice
  • Proactively identifies, analyzes, and resolves process gaps, issues, and improvement opportunities
  • Evaluates and updates system-related processes and SOPs as needed
  • Implements process improvements and collects/analyzes data to support continuous improvement initiatives.
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