Regulatory Compliance Expert
hace 7 días
We're looking for a skilled Regulatory Compliance Expert to lead our quality assurance efforts in the Inspection area. As a member of our team, you will play a key role in ensuring regulatory compliance and maintaining the highest quality standards.
About This RoleThis position requires a strong background in regulatory compliance and quality assurance. The ideal candidate will have a bachelor's degree and at least five years of direct experience as a Quality Professional in the regulated industry.
Key Responsibilities- Review and approve product manufacturing procedures
- 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
To be successful in this role, you must possess:
- Bachelor's degree with five years of direct experience as a Quality Professional in the regulated industry
- Bilingual skills in English and Spanish
- Project management skills
- Experience in trackwise system queries, deviations, triage process, GMP tasks, change controls, and validation process
We prioritize employee well-being, quality excellence, and flexibility. Our team is dedicated to delivering top-notch quality talent to our clients in the Pharmaceutical, Medical Device, and Manufacturing industries.
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