Quality Assurance Specialist

For Quality services in the Manufacturing area WHAT MAKES YOU A FIT:  The Technical Part: Bachelor's Degree with five (5) years of directly experience as Quality Assurance in the Pharmaceutical GMP regulated manufacturing. Bilingual (English & Spanish) Project Management skills Experience in: Batch record review. Leading investigations. Approving change control & CAPA records. Trackwise system queries. Triage process and Internal plant audits. The Personality Part:        Being self-motivated means that you are curious, 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 have a commitment to serving customers with high-quality research and products, to embracing a diverse work culture, and even to 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. 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? Powered by JazzHR