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Specialist QA F0223 Job In FITS LLC At Juncos, PR
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Specialist QA F0223

  • Full-Time
  • Juncos, PR
  • FITS LLC
  • Posted 3 years ago – Accepting applications
Job Description

For Quality services in the Drug Substance area.

WHAT MAKES YOU A FIT:

The Technical Part:

  • Bachelor’s Degree in Science with five (5) years of exposure in Quality within the Pharmaceutical Industry.
  • Experience in:
    • Qualification/Validation
    • Deviations and Change control
    • Trackwise
    • Investigations

The Personality Part:

  • If Quality is your middle name, keep reading! We’re looking for a passionate QA who likes to finish what they started and is confident in their ability to succeed. Sprinkle on a love of the scientific method, teamwork and, above all else, being ethical and you just might have what it takes to take on this new challenge. Bring it on!

AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)

  • Review and approve product MPs.
  • Approve process validation protocols and reports for manufacturing processes.
  • Request Quality on incident triage team. Approve Environmental Characterization reports.
  • Release of sanitary utility systems.
  • Approve planned incidents.
  • Lead investigations and site audits.
  • Own site quality program procedures.
  • Review and approve Work Orders.
  • Approve NC investigations and CAPA records and change controls.
  • Interaction with regulatory agencies.
  • Approve process validation protocols and reports for manufacturing processes.
  • Review Risk Assessments.
  • Support facilities and environmental programs.

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!

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