Compliance Engineer
Flexible & Integrated Technical Services, LLC
Gurabo, PR
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JOB DETAILS
SKILLS
Biotech and Pharmaceutical, Change Control, Construction Engineering, Corrective Action, Corrective and Preventative Action (CAPA) Systems, Customer Support/Service, Documentation, English Language, GMP (Good Manufacturing Practices), Manufacturing, Medical Equipment, Metrics, Multilingual, Procedure Development, Process Validation, Project Execution, Spanish Language, Standard Operating Procedures (SOP), Time Management, Training/Teaching, Validation Documentation
LOCATION
Gurabo, PR
POSTED
9 days ago
For Compliance, Engineering and Quality Services.
WHAT MAKES YOU A FIT: 
The Technical Part:
- Bachelor’s degree in Engineering and over five (5+) years of exposure in the Compliance and Quality activities within the Pharmaceutical industry.
- Bilingual, Spanish and English.
- Shift: Administrative and according to business needs.
- Experience in:
- Manage investigations and CAPA from the Project Execution team and Site Engineering team as required.
- Monitor GMP metrics such as Training, Change control on time closure,CAPA on time closure.
- Revise documents in TV and Kneat.
- Conduct GMP review of documentation.
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 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 take on this new challenge?
AS A PIECE OF FITS, YOU WILL:(The day-to-day on the job)
- Write, evaluate, and revise the required manufacturing documentation (SOP’s, MBR’s, etc.) and assist in providing training on scientific or technical aspects of the processes.
- Responsible for executing Corrective Action Preventive Action (CAPA’s), procedures development & revision, and process validation documentation.
- Act as facilitator for the necessary information related to the support of the existing processes and the fast tracking for documenting and implementing process modifications.
BEING A FITS PIECE COMES WITH PERKS:
- One of these is the excellent, unmatched, never-before-seen customer service of our team (trust us, you’ll be amazed). However, that’s not all we have to offer. Talk with us to find out!
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?
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