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
Similar Jobs
eCommerce • Fashion • Other • Retail • Sales • Wearables • Design
The Lead Supervisor I oversees store operations, drives sales, enhances customer experience, and leads team development through coaching and performance management.
eCommerce • Fashion • Other • Retail • Sales • Wearables • Design
The Acting Lead Supervisor I oversees store operations, coaches team members, ensures customer satisfaction, and handles merchandise logistics, including lifting and maneuvering stock.
eCommerce • Fashion • Other • Retail • Sales • Wearables • Design
The Stylist assists customers in selecting products that fit their style, provides styling advice, and ensures a smooth purchase experience. They enhance customer engagement and maintain operational excellence in a retail environment.
What you need to know about the Charlotte Tech Scene
Ranked among the hottest tech cities in 2024 by CompTIA, Charlotte is quickly cementing its place as a major U.S. tech hub. Home to more than 90,000 tech workers, the city’s ecosystem is primed for continued growth, fueled by billions in annual funding from heavyweights like Microsoft and RevTech Labs, which has created thousands of fintech jobs and made the city a go-to for tech pros looking for their next big opportunity.
Key Facts About Charlotte Tech
- Number of Tech Workers: 90,859; 6.5% of overall workforce (2024 CompTIA survey)
- Major Tech Employers: Lowe’s, Bank of America, TIAA, Microsoft, Honeywell
- Key Industries: Fintech, artificial intelligence, cybersecurity, cloud computing, e-commerce
- Funding Landscape: $3.1 billion in venture capital funding in 2024 (CED)
- Notable Investors: Microsoft, Google, Falfurrias Management Partners, RevTech Labs Foundation
- Research Centers and Universities: University of North Carolina at Charlotte, Northeastern University, North Carolina Research Campus
