Quality Assurance - NPI
Flexible & Integrated Technical Services, LLC•Juncos, PR
About The Position
The Quality Assurance role supports QA Services in the NPI area. The position represents Quality Assurance on the NPI team and performs quality oversight across manufacturing, validation, investigations, change control, audits, site quality programs, and lot disposition. The schedule is an administrative shift, with work according to business needs.
Requirements
- Bachelor's degree.
- Four years of experience within the pharmaceutical or regulated industry.
- Bilingual in English and Spanish.
- Project management skills.
- Experience in NPI, Change Control, FATs, Validation, and PPQs.
Responsibilities
- 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 sanitary utility systems and approve planned incidents.
- Represent QA on the NPI team.
- Lead investigations and site audits.
- Own site quality program procedures.
- Serve as designee for the QA manager on the local CCRB.
- Review Risk Assessments.
- Support Automation activities, 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.
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What This Job Offers
Job Type
Full-time
