Specialist QA
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Summary
On-site Quality Assurance specialist at a GMP manufacturing site in Juncos, Puerto Rico: reviews and approves change controls, deviations, CAPAs, protocols, reports, and SOPs, supports packaging/inspection operations, and collaborates with Manufacturing, Engineering, and Process Development. Requires GMP QA experience, GDP and electronic quality systems knowledge, and bilingual English/Spanish ski
We are seeking a Specialist QA with GMP manufacturing experience in Quality Assurance, including review and approval of change controls, deviations, CAPAs, protocols, reports, and procedures. Experience supporting packaging/inspection operations, strong knowledge of GDP and electronic quality systems, and the ability to collaborate effectively with Manufacturing, Engineering, and Process Development are highly desired.
Requirements
- Degree in a related field with applicable experience:
- Doctorate, Master's + 2 years of experience, Bachelor's + 4 years of experience, Associate's + 8 years of experience, High School Diploma/GED + 10 years of experience.
- Bilingual English and Spanish communication skills.
- Experience in Quality Assurance within a GMP-regulated environment.
- Experience reviewing and approving Change Controls, Deviations, CAPAs, Protocols, Reports, and SOPs.
- Experience supporting packaging and inspection operations.