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Operation Process Compliance Specialist

FITS LLC Humacao, PR

  • Posted: over a month ago
  • Contractor
Job Description

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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FITS LLC

Address

Humacao, PR
USA

Industry

Business

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