The QA Specialist will oversee quality assurance actions related to drug substances, approve protocols, lead investigations and audits, and manage quality programs.
For Quality Assurance services in the 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: Administrative and according to business needs.
- Available to work weekends.
- Experience in:
- New Product Introduction (NPI)
- Validation process
- Change Control
- PASx/MES application, Risk assessment, MAXIMO, SAP and LIMS
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 the incident triage team.
- Approve Environmental Characterization reports.
- Release of sanitary utility systems.
- Approve planned incidents.
- Represent QA on the 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?
Top Skills
Lims
Maximo
Mes
Pasx
SAP
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