Support product transfer activities by ensuring compliance with validation processes for quality IT systems, coordinating with clients and personnel, and handling non-conformance events.
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.
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?
Top Skills
Agile
Compliance Wire
Gallup On-Line Tool
Hr - Abra Suite
Maximo
MS Office
Mro Program
SAP
Teds
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