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.

Requirements

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

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

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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