For Quality Assurance services in the Manufacturing/Engineering area.
WHAT MAKES YOU A FIT:
The Technical Part:
- Bachelor's Degree in Engineering and at least three (3) years of previous exposure to Quality activities within the Pharmaceutical or Medical Devices industry.
- Bilingual, Spanish and English (good communication)
- Shift: Administrative & according to business needs
- Experience in:
- Validation Life Cycle
- Change Control
- Documentation
- GMP & GDP regulations
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)
- Support the implementation of effective quality engineering processes for new products, processes, and technology.
- Provides support to the validation and certification of process, test methods, equipment, software, utilities, and facilities as required.
- Generates test protocols, monitors testing, issues qualification test reports and approves qualifications plans/reports.
- Provides support on activities, documents and records requiring Quality Engineering review and/or approval as deemed necessary.
- Alerts the organization to issues in time to resolve potential adverse effects on the customer, company image, or reputation of the business.
- Works with multi-functional teams to establish project plans and ensure uninterrupted support to new projects balanced with manufacturing operations.
- Develops standard operating procedures, specifications, and provides technical transfer and validation support.
- Utilizes appropriate risk management tools to prevent unanticipated failure modes and improve capability of processes.
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?
Skills Required
- Bachelor's Degree in Engineering
- At least 3 years of quality experience in Pharmaceutical or Medical Devices industry
- Bilingual: Spanish and English
- Experience with Validation Life Cycle
- Experience with Change Control
- Experience with Documentation and generating test protocols/qualification reports
- Knowledge of GMP and GDP regulations
- Experience using risk management tools to assess and mitigate failure modes
What We Do
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 We The Right Piece For You? We are: Experienced and knowledgeable in the Industry Committed to Safety Always compliant with FDA Regulations & Audits Cost Effective Proven successful track record Over ten (10) years of experience If you'd like to apply to any of our open positions, send us your updated resume in Word or PDF Format to [email protected]
