Regulatory Compliance Expert

hace 7 días


Juncos, Puerto Rico Flexible & Integrated Technical Services, Llc A tiempo completo

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 Role

This 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
Requirements

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
Our Values

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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