Quality Applications Specialist
About The Position
Conducts a compliant validation process for quality information technology systems requiring formal validation documentation (including standard operating procedures) under applicable federal regulations. Coordinates activities with clients, programmers/developers, and operating personnel, both domestically and, as appropriate, globally. Identifies current and anticipated requirements for compliant computerized operations and suggests methods for the identification, implementation, and maintenance of procedures, actions, and documentation necessary to assure compliance with federal and international regulations governing user applications. Reports on the status of validation activities to fulfill regulatory requirements. Keeps abreast of changing federal and international regulatory requirements, government audit policies, and new validation techniques. Performs system administration and configuration of quality information technology systems. Supports day-to-day manufacturing activities, leads and participates in investigations, and drives improvement projects within the manufacturing environment. Other duties may be assigned.
Requirements
- Bachelor’s degree in Science or Engineering
- Minimum of 2 years of relevant experience
- Experience in manufacturing environments
- Experience with Process Validation
- Ability to understand and follow change control processes
Nice To Haves
- 2–3 years’ experience with Sterilization Validation / Microbiology (desirable)
- Investigation and root cause analysis skills
- CAPA (Corrective and Preventive Actions) knowledge or experience
Responsibilities
- Conduct a compliant validation process for quality information technology systems
- Coordinate activities with clients, programmers/developers, and operating personnel
- Identify current and anticipated requirements for compliant computerized operations
- Suggest methods for the identification, implementation, and maintenance of procedures, actions, and documentation necessary to assure compliance with federal and international regulations
- Report on the status of validation activities to fulfill regulatory requirements
- Keep abreast of changing federal and international regulatory requirements, government audit policies, and new validation techniques
- Perform system administration and configuration of quality information technology systems
- Support day-to-day manufacturing activities
- Lead and participate in investigations
- Drive improvement projects within the manufacturing environment
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
