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Flexible & Integrated Technical Services, LLC

Specialist QA

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

Pharmaceutical Manufacturing · 201-500 employees

3 d ago
qa Mid (2-5 yrs) Contractor United States
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About the role

The Specialist QA will lead investigations, audits, and incident triage while approving process validation protocols and quality records. They are responsible for ensuring compliance in manufacturing processes, utility systems, and site quality programs.

What they look for

Quality Assurance Change Control Deviations CAPA Protocol Review Packaging Operations Inspection Operations GDP Electronic Quality Systems Project Management Risk Assessment Incident Investigation Site Audits Manufacturing Support Automation Support Lot Disposition

Requirements

Candidates must hold a Bachelor's degree and possess at least four years of experience in the pharmaceutical or regulated industry. Proficiency in English and Spanish is required, along with strong knowledge of quality systems and regulatory standards.

Full description

For QA Services in the Technical Team area.

WHAT MAKES YOU A FIT: 

The Technical Part:

  • Bachelor's Degree with four (4) years of experience within the pharmaceutical or regulated industry.
  • Bilingual (English & Spanish).
  • Project Management skills.
  • Shift: Administrative and according to business needs.
  • Experience in:• Quality Assurance, including review and approval of change controls, deviations, CAPAs, protocols, reports, and procedures.
  • Packaging/inspection operations, strong knowledge of GDP and electronic quality systems, and the ability to collaborate effectively with Manufacturing, Engineering, and Process Development.

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 manufacturing processes.
  • Request Quality on incident triage team.
  • Approve Environmental Characterization reports.
  • Release of sanitary utility systems.
  • Approve planned incidents.
  • Represent QA on NPI team.
  • Lead investigations.
  • Lead site audits.
  • Own site quality program procedures.
  • Designee for QA manager on local CCRB.
  • Review Risk Assessments.
  • Support Automation activities.
  • Support facilities and environmental programs.
  • Review and approve Work Orders.
  • Review and approve EMS/BMS alarms.
  • Approve NC investigations and CAPA records.
  • Approve change controls.
  • Provide lot disposition and authorize lots for shipment.

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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