For Quality services in the Quality Assurance Drug Substance area.
WHAT MAKES YOU A FIT:
The Technical Part:
Bachelor's Degree with five (5) years of direct experience as a Quality Professional in the regulated industry.
Bilingual (English & Spanish)
Project Management skills
Shift: Non-standard and according to business needs. Available to work 12-hour shifts and weekends (AM and PM).
Experience in:
Manufacturing Process Audit and Batch Record Review experience.
DAI process, PASx/MES application, MAXIMO, SAP and LIMS.
The Personality Part:
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 master production records (MPs).
Approve process validation protocols and reports for manufacturing processes.
Request Quality to join the incident triage team.
Approve Environmental Characterization reports.
Release sanitary utility systems.
Approve planned incidents.
Represent Quality Assurance on the New Product Introduction (NPI) team.
Lead investigations.
Lead site audits.
Own site quality program procedures.
Approve non-conformance investigations and Corrective and Preventive Action (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?
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