Quality Specialist- Non-Standard Shift

FITS, LLC; Juncos (PR); On-site; USD 70,000 - 110,000; Full time

Job summary

FITS, LLC in Puerto Rico is seeking QA Services professionals for Drug Substance operations. The role requires a Bachelor’s Degree with four years in pharma, bilingual English/Spanish, and strong project management exposure.

You will support quality and manufacturing operations, review batch records, ensure documentation compliance, and manage electronic systems while handling inventory control and timely operations.

Qualifications

• Bachelor’s Degree with four (4) years of experience in the pharmaceutical or regulated industry.
• Bilingual (English & Spanish).
• Project Management skills.
• Shift: Non-Standard shift, per business needs.
• Experience in Quality and Manufacturing operations.
• Batch Record Review, documentation compliance, electronic systems management, inventory control, and timely operations.

Responsibilities

• Review and approve product MPs.
• Approve 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 and site audits.
• Own site quality program procedures.
• Designee for QA manager on local CCRB.
• Review Risk Assessments.
• Support Automation activities and 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

Project Management

Bilingual English/Spanish

Quality & Manufacturing

Education

Bachelor’s Degree

Job description

For QA Services in the Drug Substance a rea.

WHAT MAKES YOU A FIT:

The Technical Part:

• Bachelor'sDegree with four(4)years of experiencewithin the pharmaceutical or regulated industry.
• Shift: Non-Standardshift, and according to business needs.
• Experience in:
  • Quality and Manufacturing operations.
  • Batch Record Review, documentation compliance, electronic systems management, inventory control, and timely operational.

For QA Services in the Drug Substance a rea.

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: Non-Standardshift, and according to business needs.
• Experience in:
  • Quality and Manufacturing operations.
  • Batch Record Review, documentation compliance, electronic systems management, inventory control, and timely operational.

T he 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-notch quality talent.We're FITS!

Are you the next piece?