Operation Process Compliance Specialist
FITS LLC Humacao, PR
- Posted: over a month ago
For Compliance services in the Quality area
WHAT MAKES YOU A FIT:
The Technical Part:
- Bachelor’s Degree in Science, Pharmacy or Engineering & five (5) years of exposure in the Oral Solid Dosage Manufacturing industry.
- Bilingual (English & Spanish)
- Experience in:
- Technical Writing
- Root Cause Analysis
- Interpreting Statistical Data
- Operational and Scientific Investigations
- cGMP’s, OSHA, EPA and other Regulatory Standards
The Personality Part:
- If you have a commitment to serving customers with high-quality research and products, to embracing a diverse work culture, and even to the environment, you might just be what we’re looking for!
AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)
- Execute and ensure that all Quality Events and CAPAs are closed within the established timeframe, utilizing the right tools to measure effectiveness to prevent reoccurrence.
- Monitor and assure that action plans have been implemented to eliminate reoccurrence.
- Review and provide input to regulatory submissions applicable to area of responsibility.
- Interact with regulatory compliance agencies with respect to Quality Events.
- Provide written responses to regulatory observations as well as ensure implementation of commitments.
- Lead QE’s and CAPA’s trend evaluation.
- Support establishment of process monitoring parameters and control limits.
- Manage Quality Council metrics and share trends and gaps with management.
- Evaluate and revise manufacturing documentation resulting from a compliance gap.
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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