For Quality services in the Manufacturing area.
WHAT MAKES YOU A FIT:
The Technical Part:
- Bachelor’s Degree in Engineering or related field and at least four (4) years of previous exposure to Audit Observations, Investigations & CAPA activities within the regulated industry.
- Bilingual: (Spanish and English)
- Shift: Administrative & according to business needs
- Experience in:
- NC/CAPA & Audit Observations process
- FDA 21 CFR and global medical device regulations and standards
- 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)
- Initiate NRs as required.
- Perform the investigations in ETQ for NRs/CAPAs and Audit Observations for Operations.
- Plan and execute product disposition.
- Plan and execute actions related to NC/CAPA & Audit Observations.
- Close the investigations and Product Dispositions on time.
- Identifies and escalates to Operations Managers any compliance issues and their potential impact across the franchise so that they can be effectively resolved.
- Reviews and analyzes quality trends with the manufacturing team.
- Considering quality trends provides direction in setting work priorities for process enhancement.
- Provides leadership and guidance to cross-functional, multilevel technical teams to ensure that causes of non-conformance are identified and understood, and that sound corrective/preventive actions are implemented.
- Evaluation of the implemented corrective and preventive actions against trends to assess the effectiveness of the same.
- Leads investigations of the negative trends and, in alignment with the Process Engineer and the Manufacturing Manager, facilitates the implementation process.
- Analysis of data and based on the trends recommends actions for process, equipment, and system improvement.
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 or related field
- At least four (4) years exposure to Audit Observations, Investigations & CAPA activities within a regulated industry
- Bilingual: Spanish and English
- Experience with NC/CAPA and Audit Observations processes
- Knowledge of FDA 21 CFR and global medical device regulations and standards
- Knowledge of GMP and GDP regulations
- Experience performing investigations in ETQ (quality management system)
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]
