OXFORD GLOBAL RESOURCES INC
Maple Grove, MN, USA
Summary: Perform tactical work and review a variety of documents, protocols, and reports. Project Details: Exhibit varying levels of experience and a solid progression of work and/or training Document, review and batch disposition of API and drug product used in Phase 1-3 clinical studies Review and approve manufacturing records, change controls, investigations and analytical data Review and approve test methods and method validations Review manufacturing validation protocol and reports Job Experience: Experience in small molecule manufacturing and contract manufacturing Bachelor's degree in Engineering, Chemistry, Biology, or other related discipline A minimum of 5+ years' work experience in the Quality organization of a Medical Device and/or Pharmaceutical company Knowledge and experience in CAPA; Root Cause Investigation; Validation (Process, Test Method, Software, and Design); Environmental Monitoring, Manufacturing operation, etc. Excellent verbal and written communication...
