Job Description

Quality role to support product transfer activities in the engineering area.

WHAT MAKES YOU A FIT:

The Technical Part:

• Bachelor's Degree in Engineering or Science with at least (2) two years of experience within the regulated industry.
• Bilingual (English & Spanish).
• Good communication and writing skills.
• Shift: 1st and according to business needs (Availability to work overtime and weekends when necessary).
• Certification: Lean Six Sigma
• Experience in:
  • Microsoft Office, Agile, HR - ABRA Suite, Maximo, MRO Program, SAP, TEDS, Agile, Compliance Wire, Gallup On-line Tool.
  • Evaluating, Investigating & Completion of Non- Conformance.
  • Identifying and Implementing Corrective/Preventive Actions.

The Personality Part:

• 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!

AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)

• Conducts a compliant validation process for quality information technology systems, which requires formal validation documentation.
• Coordinates activities with clients, programmers/developers, and operating personnel, domestic and, as appropriate, global.
• Identifies current and anticipated requirements for compliant computerized operations and suggests methods for the identification and implementation.
• Maintenance of the procedures, actions, and documentation necessary to ensure compliance with the appropriate federal and international regulations.
• Reports on the status of validation activities to fulfill regulatory requirements.
• Performs system administration and configuration of quality information technology systems.
• Performs investigation of non-conformance events.
• Initiates, recommends, and provides solutions to the Non-Conforming Product as per procedures.
• Verifies the implementation and effectiveness of non-conforming CAPA.
• Executes job responsibilities as established in the procedures.
• Follows the documentation procedures Non- Conformance Resolution.
• Investigation ( Data gathering of Quality issue)
• Lead complaint activities with the Operating Units members.

WHO WE ARE:

We are a Service Provider company different from the rest. We pride ourselves in how we treat the most important piece of our company's puzzle: you! We integrate Engineering, Construction, Maintenance, Utilities and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device and Manufacturing industry clients with top-notch quality talent. We're FITS!

Are you the next piece?