Quality Specialist- Non Standard Shift

 For QA Services in the Quality Assurance Drug Substance area.

WHAT MAKES YOU A FIT: 

The Technical Part:

• 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. 

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 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?