Quality Specialist- Non Standard Shift

FITS LLC; Juncos (PR); On-site; USD 90,000 - 120,000; Full time

Job summary

FITS LLC in Puerto Rico is seeking a senior QA professional to join our pharmaceutical services team. The role focuses on QA review, process validation, and site quality oversight in a regulated environment.

You will collaborate with cross-functional teams, lead investigations, and ensure CAPA and change-control processes are compliant with cGMP standards while coordinating with manufacturing and automation initiatives.

Qualifications

• Bachelor's degree with five (5) years of experience within the pharmaceutical or regulated industry.
• Bilingual (English & Spanish).
• Project Management skills.
• Shift: Non Standard Shift and according to business needs. Available to work AM (5am to 5pm) and Night (5:00pm-5:00AM)
• Experience in: Quality Assurance (PQA) review, approval, and tracking of cGMP processes, procedures, testing method.
• Batch record review, MES, EBR, SAP, EDMQ, DQMS, Trackwise.
• Quality Systems such as deviations, CAPA, and change control.
• Validation Process.

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

Bachelor's degree

Bilingual (English & Spanish)

Project Management

QA experience

Leadership

Regulatory compliance

Quality Systems

Validation

Shift availability

Education

Bachelor's degree in Pharmaceutical/regulated industry

Tools

SAP

MES

EDMQ

DQMS

Trackwise

Job description

WHAT MAKES YOU A FIT:

The Technical Part:

• Bachelor'sDegree with five (5)years of experiencewithin the pharmaceutical or regulated industry.
• Bilingual (English & Spanish).
• Project Management skills.
• Shift: Non Standard Shiftand according to business needs.
  • Available to work AM (5am to 5pm) and Night (5:00pm-5:00AM)
• Experience in:
  • Quality Assurance (PQA) review, approval, and tracking of cGMP processes, procedures, testing method.
  • Batch record review, MES, EBR, SAP, EDMQ, DQMS, Trackwise.
  • Quality Systems such as deviations, CAPA, and change control..
  • Validation Process.

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-notch quality talent.We're FITS!

Are you the next piece?