Specialist QA- 01

 For QA services in the DP Quality Assurance area.

WHAT MAKES YOU A FIT: 

The Technical Part:

• Bachelor’s degree in sciences with four (4) years in the regulated industry.
• Bilingual (English & Spanish)
• Project Management skills
• Shift: Administrative and according to business needs. 
• Experience in:
  • Quality Systems such as Deviations (Non-conformities, CAPA, and Change Control).
  • Documentation platforms (CDOCS), Maximo, Trackwise, LIMS, electronic batch record (MES) and SAP.
  • Validation of GxP applications, Validation Master Plan, (IQ), (OQ), and (PQ) Protocols, Test Scripts. 
  • Completion/Summary Reports approvals as per the compliance requirements.
  • Quality Contact for sophisticated projects involving new drug substance/products, commissioning and qualifications.

• Being self-motivated means that you are curious and anxious to explore all possibilities without anyone telling you to (while also following instructions, of course). It means you’re creative, with such an eye for detail, that nothing gets past you. If this sounds like you, and if you commit to serving customers with high-quality research and products, embracing a diverse work culture, and even the environment, you might just be what we’re looking for!

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?