Specialist QA F0223

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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