Specialist QA
Flexible & Integrated Technical Services, LLC
- Juncos, PR
- Permanente
- Tiempo completo
- Bachelor’s Degree with five (5) years of directly experience as Quality Professional in the regulated industry.
- Bilingual (English & Spanish)
- Project Management skills
- Shift: Administrative and according to business needs.
- Experience in:
- Electronic batch record
- Syringe/Vial Manual inspection
- 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!
- 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.