Perform tactical work and review a variety of documents, protocols, and reports.
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
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 skills
Demonstrate ability to effectively collaborate and partner with all levels of management while maintaining an appropriate assertive style is critical
Strong analytical skills
Effective project management and organizational skills are essential
Knowledge and understanding of quality
Manufacturing processes and procedures, planning, supply chain, inventory management
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