On-site Quality IT Validation & Compliance Specialist

Medial Group; Villalba (PR); On-site; USD 60,000 - 90,000; Full time

Job summary

Medial Group in Villalba, Puerto Rico is seeking a QA/Validation Specialist to lead compliant validation activities for manufacturing IT systems, including documentation such as SOPs, and to ensure adherence to federal and international regulations.

You will coordinate with clients, developers, and production personnel, perform system administration and change control, support investigations, and drive CAPA and process validation improvements on-site.

Qualifications

• Bachelor's degree in Science or Engineering.
• Minimum of 2 years of relevant experience.
• 2–3 years' experience with Sterilization Validation / Microbiology.
• Experience in manufacturing environments.
• Experience with Process Validation.
• Ability to understand and follow change control processes.
• Investigation and root cause analysis skills (Nice to Have).
• CAPA knowledge or experience (Nice to Have).
• Willing to work 100% On-site in Villalba.

Responsibilities

• Conducts a compliant validation process for quality information technology systems requiring formal validation documentation under applicable federal regulations.
• Coordinates activities with clients, programmers/developers, and operating personnel, both domestically and globally as appropriate.
• Identifies requirements for compliant computerized operations and suggests procedures and documentation to assure regulatory compliance.
• Reports on the status of validation activities to fulfill regulatory requirements.
• Keeps abreast of changing federal and international regulatory requirements, audit policies, and validation techniques.
• Performs system administration and configuration of quality information technology systems.
• Supports day-to-day manufacturing activities, leads investigations, and drives improvement projects within the manufacturing environment.

Skills

Sterilization Validation

Microbiology

Regulatory compliance

Change control

CAPA knowledge

Education

Bachelor's degree in Science or Engineering

Job description

Medial Group in Villalba, Puerto Rico is seeking a QA/Validation Specialist to lead compliant validation activities for manufacturing IT systems, including documentation such as SOPs, and to ensure adherence to federal and international regulations.

You will coordinate with clients, developers, and production personnel, perform system administration and change control, support investigations, and drive CAPA and process validation improvements on-site.