Quality Applications Specialist

Job Description

• 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

Must Have :

2–3 years’ experience with Sterilization Validation / Microbiology (desirable)

Experience in manufacturing environments

Experience with Process Validation

Ability to understand and follow change control processes

Nice to Have :

Investigation and root cause analysis skills

CAPA (Corrective and Preventive Actions) knowledge or experience