Specialist Manufacturing
On-site · Juncos, Juncos, Puerto Rico
Job Summary
Specialist Manufacturing role supporting manufacturing operations and quality systems in bioprocessing. Responsibilities include initiating, revising, and approving procedures; owning documents; monitoring process performance; troubleshooting operations; generating training materials and delivering technical training; supporting deviation investigations, NC/CAPA closures, trend evaluations, and process validation activities; participating in regulatory inspections and NPI efforts; providing project management support for process or equipment modifications; and assisting with CCRB packages. Requires strong technical writing, communication with manufacturing, process development, and quality teams, and ability to work with minimal supervision.
Required Qualifications
- Doctorate OR Master's + 2 years of Manufacturing Operations experience OR Bachelor's + 4 years of Manufacturing Operations experience OR Associate’s + 8 years of Manufacturing Operations experience OR High School/GED + 10 years of Manufacturing Operations experience
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