Quality Applications Specialist
Flexible & Integrated Technical Services Ver todas las vacantes
- Villalba, PR
- Permanente
- Tiempo completo
- Bachelor's Degree in Engineering with at least three (3) years of experience within the regulated industry.
- Bilingual (English & Spanish).
- Good communication skills.
- Shift: 1st and according to business needs.
- Experience in:
- Sterilization
- Final Pack
- Process Validation, Statistical Analysis, Process Failure Mode, and First Time Quality.
- Besides being able to provide guidance, you're able to work independently to solve problems and improve every aspect of the project. Add to this a commitment to serving customers with high-quality research and products, to embracing a diverse work culture, and even to the environment, and you might just be what we’re looking for!
- Conduct a compliant validation process for quality information technology systems, producing all required formal validation documentation, including SOPs, in accordance with applicable federal regulations.
- Coordinate validation‑related activities with clients, programmers/developers, and operating personnel across domestic teams and, when appropriate, global partners.
- Identify current and anticipated requirements for compliant computerized operations and suggest effective methods for establishing, implementing, and maintaining the procedures, actions, and documentation needed to meet federal and international regulatory standards.
- Report on the status of validation activities to ensure regulatory requirements are fulfilled and stakeholders remain informed.
- Stay informed on evolving federal and international regulatory requirements, government audit expectations, and emerging techniques relevant to validation and compliance.
- Perform system administration and configuration tasks for quality information technology systems to support validated and compliant system performance.