Quality Specialist- 02

FITS LLC; Juncos (PR); On-site; USD 85,000 - 115,000; Full time

Job summary

FITS LLC seeks a QA professional for the Drug Substance area to ensure product quality and regulatory compliance across our island operation and the US. The role emphasizes collaboration with engineering and manufacturing to maintain robust quality processes.

Responsibilities include reviewing MPs, validating processes, leading investigations, site audits, CAPAs, change controls, and lot disposition, while supporting environmental and automation programs.

Qualifications

• Bachelor's degree with four years of experience in pharma or regulated industry.
• Bilingual in English and Spanish.
• Project management skills.
• Shift: Administrative shift, and according to business needs.
• Experience in quality organization supporting deviations, validation reports, qualifications, investigations.

Responsibilities

• 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.
• 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

Quality investigations

Quality systems support

Deviation handling

Education

Bachelor's degree

Job description

For QA Services in the Drug Substance area.

WHAT MAKES YOU A FIT:

The Technical Part:

• Bachelor'sDegree with four(4)years of experiencewithin the pharmaceutical or regulated industry.
• Bilingual (English & Spanish).
• Project Management skills.
• Shift: Administrative shift, and according to business needs.
• Experience in:
  • Quality organization supporting deviations, validation reports, qualifications, investigations.

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)

• 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.
• 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-quality talent.We're FITS!

Are you the next piece?