The QC Specialist I will support QC Raw Material Program and Testing activities, including onboarding materials, conducting raw material risk assessments, conduct inspections and testing, and execute the daily operation in the laboratory.
Requirements
- BS in a scientific discipline with at least 5 years’ experience in GMP pharmaceutical / biotech industry within Quality Control, MSAT, Process Development or related area to Raw Materials technical expertise
- Experience with raw material testing programs and quality control methodologies (FT-IR, Raman, NIR, Dot-blot, ELISA, HPLC, pH, Visual Inspection, etc.)
- Experience with SAP Quality Module
- Experience with interpreting and applying international compendial test monographs
- Ability to communicate and work independently with scientific/technical personnel
- Experince in presenting routine disposition metrics such as Lots Release per Month, number of lots pending disposition
- Strong knowledge of GMPs, SOPs, and Quality system processes
- Excellent organizational skills
Benefits