Quality Engineer
Current• Participate as a project team member on customer projects.• Review and approve Process Development Specifications (PDS) per GMP requirements.• Review and approve Sampling Plans per PDS requirements.• Responsible for SAP material set up, issuance and approval of inspection plans and incoming goods.• Responsible for review and approval of master batch records.• Responsible for release of finished product batches including approval and issuance of Certificate of Analysis and Certificate of Disposition• Responsible for tracking metrics for site KPI and Quality Management Review• Participate in Customer Audits