Validation Analyst

About the job

We are constantly looking to add to our core talent. If you are seeking a career that is challenging and rewarding, a work environment that is diverse and dynamic, look no further Haemonetics is your employer of choice.

Job Details

The individual conducts a compliant validation process for systems which requires formal validation documentation (including standard operating procedures) under appropriate federal regulations. Coordinates activities with clients and programmers/developers. Identifies current requirements and assures compliance according to the appropriate regulations which govern the user's applications. Keeps abreast of changing regulatory requirements and the availability of current techniques.

• This role is responsible to analyze, draft, design and execute validation strategies and develop protocols.
• Compile and analyze validation data, prepare reports and develop solutions for changes and/or improvements.
• Conduct or oversee validation testing in the field.
• Demonstrate commitment to the quality policy.
• Document work methods and procedures.
• Assist in the revision and enhancement of validation programs to accomplish corporate objectives.
• Identify, document and report defects according to procedure.
• Organize and maintain library of validation documentation, scripts and other files.
• Oversee validation tasks and resources that result in timely deployment of validation services within project timeline.
• Provide assistance to client during on site validation activities.
• Provide assistance to other team members as needed.
• Creates and executes validation planning for projects of moderate scope and complexity and revises as appropriate to meet changing needs and requirements.
• Remains abreast of developments in the field of manufacturing, computer technology, blood banking, quality and validation, as applicable.
• Schedule, plan and lead multiple projects, including the delivery of validation services and materials to clients and day to day oversight of validation cases.
• Track and communicate validation status to clients and management.
• Work closely with clients to measure the effectiveness of the validation programs.

Minimum Required Education And Experience

• Bachelor's degree in clinical laboratory science or equivalent or Science or Engineering Required
• 5-years of experience in validation and / or commissioning Blood Bank, Transfusion service and/or Donor Center experience is preferred

Knowledge, Skills And Abilities

• Knowledge of current industry practices and cGMP requirements related to validation tasks in a regulated environment.
• Technical writing skills
• Advanced demonstrated analytical skills
• Demonstrated written communication skills.
• Demonstrated customer service skills.
• Strong verbal communication and listening skills.

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