Quality Applications Specialist

Medial Group; Villalba (PR); Sur place; USD 60 000 - 90 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Sterilization Validation

Microbiology

Regulatory compliance

Change control

CAPA knowledge

Formation

Bachelor's degree in Science or Engineering

Description du poste

Villalba, Puerto Rico | Posted on 09/11/2025

• 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

*Willing to work 100% On-site in Villlalba*