Job Description

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.

Responsibilities

The list of essential functions, as outlined herein, is intended to be representative of the duties and responsibilities performed within this classification. It is not necessarily descriptive of any one position in the class. The omission of an essential function does not preclude management from assigning duties not listed herein if such functions are a logical assignment to the position.

• 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.

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty and responsibility satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

EDUCATION AND/OR EXPERIENCE:

Bachelor’s degree and 2 years of experience in related field. Prior experience in laboratory testing, blood products, biotherapies, or biologics manufacturing environments preferred. Demonstrated proficiency in technical writing, process mapping, and computer applications required.

CERTIFICATES, LICENSES, REGISTRATIONS AND DESIGNATIONS:

Six Sigma (Green Belt, Black Belt, Master Black Belt), Lean, ISO 9001, or ASQ (American Society for Quality) credentials preferred

KNOWLEDGE, SKILLS AND ABILITIES:

• 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

PHYSICAL REQUIREMENTS:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Functions involve the ability to exert light physical effort usually involving some lifting, carrying, pushing and/or pulling of objects and materials of light weight (up to 20 pounds). May involve some climbing, balancing, stooping, kneeling, crouching, crawling, walking or standing.

ENVIRONMENTAL REQUIREMENTS:

The work environment characteristics described here are representative of those an employee may encounter while performing the essential functions of this job.

Functions are regularly performed inside without potential for exposure to adverse conditions, such as inclement weather, atmospheric elements and pathogenic substances. The noise level in the work environment is usually moderate.