Quality Application Specialist - 119
Villalba, PR, Puerto Rico
Contracted
Medical Devices
Mid Level
For Quality services in the Manufacturing area.
WHAT MAKES YOU A FIT: .png)
The Technical Part:
- Bachelor’s Degree in Engineering and three (3) years of exposure within the Pharmaceutical & Medical Devices Industry.
- Bilingual: Spanish and English
- Soft Skills: Excellent Communication skills
- Shift: 1st Shift.
- Experience in:
- Process Validation
- Statistical Techniques
- Process Failure Mode and First Time Quality
The Personality Part:
- Our Next Piece is someone who treats everyone they meet like family, especially our resources, clients, and team members. In other words, being a customer service pro is one of your (many) talents. Being the Piece means you're full of bright ideas and eager to innovate, always bringing top-quality results to the table. Are you ready to Be The Piece?
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 under appropriate federal regulations.
- 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.
- Identification, implementation, and maintenance of the procedures, actions, and documentation necessary to ensure compliance according to the regulation.
- Reports on the status of validation activities to fulfill regulatory requirements.
- Keeps abreast of changing federal and international regulatory requirements, government audit policies, and the availability of current techniques.
- Performs system administration and configuration of quality information technology systems.
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?
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