Specialist QA

FITS LLC; Juncos (PR); On-site; USD 65,000 - 90,000; Full time

Job summary

FITS LLC in Puerto Rico seeks a Quality Assurance professional for the Technical Team Area to support QA services in pharmaceutical manufacturing. You will review change controls, deviations, CAPAs, and protocols, and ensure compliance with GDP and electronic quality systems.

You will lead investigations, approve environmental reports, release sanitary utility systems, and coordinate with Manufacturing, Engineering, and Process Development to keep site quality programs robust.

Qualifications

• Bachelor's degree in a relevant field with 4 years of pharmaceutical or regulated industry experience.
• Bilingual in English and Spanish.
• Project management skills.
• Experience in QA, including review/approval of change controls, deviations, CAPAs, protocols, reports, and procedures.
• Packaging/inspection operations knowledge, GDP, and electronic quality systems; ability to collaborate with Manufacturing, Engineering and Process Development.

Responsibilities

• 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.

Skills

Bilingual English & Spanish

Project management

QA experience

GDP knowledge

Electronic quality systems

Cross-functional collaboration

Education

Bachelor's degree

Job description

For QA Services in the Technical Team Area.

WHAT MAKES YOU A FIT:

The Technical Part:

• Bachelor'sDegreewith four (4)years of experiencewithin the pharmaceutical or regulated industry.
• Bilingual (English & Spanish).
• Project Management skills.
• Shift: Administrative and also 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 companydifferent 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 industryclients with top-notch quality talent. We're FITS!

Are you the next piece?