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Flexible & Integrated Technical Services, LLC

Sr Specialist QA

Flexible & Integrated Technical Services, LLC Juncos, Puerto Rico, United States

Pharmaceutical Manufacturing · 201-500 employees

20 h ago
qa Senior (5-10 yrs) Contractor United States
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About the role

The specialist will approve process validation protocols, release sanitary utility systems, and lead investigations. They will also represent Quality on incident triage and NPI teams while managing site quality program procedures.

What they look for

Quality Assurance Project Management Commissioning and Qualification Computer System Validation Equipment Validation Risk Assessment Change Control KNEAT CDOCS Scada Trackwise Maximo Process Validation Incident Investigation Environmental Characterization Regulatory Compliance

Requirements

Candidates must hold a Bachelor's degree and possess at least six years of experience in the pharmaceutical or regulated industry. Proficiency in English and Spanish is required, along with technical expertise in validation, risk assessment, and quality control systems.

Full description

For QA Services in the Technical Team area.

WHAT MAKES YOU A FIT: 

The Technical Part:

  • Bachelor's Degree with six (6) years of experience within the pharmaceutical or regulated industry.
  • Bilingual (English & Spanish).
  • Project Management skills.
  • Shift: Administrative and according to business needs.
  • Experience in:• Facilities and Utilities Commissioning and Qualification.
  • Computer System and Equipment Validation.
  • Risk Assessments and Change Control.
  • KNEAT, CDOCS, Scada, Trackwise, Maximo. 
  • Documents revision and approval.

The Personality Part:    • Picture yourself in a lab… with all the equipment you need to put your multitasking, scientific, creative (to come up with all those experiments!) skills to work. Picture as well an environment of healthy competition, teamwork, being ethical and of using the scientific method in all ways possible. If you like how this sounds, then this might be the job for you. Bring it on!

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

  • Approve process validation protocols and reports for mfg. processes.
  • Represent Quality on incident triage team.
  • Approve Environmental Characterization reports.
  • Release of sanitary utility systems.
  • Approve planned incidents.
  • Represent QA on NPI team.
  • Lead investigations.
  • Own site quality program procedures.
  • Designee for QA manager on local CCRB.

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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