Quality Assurance Specialist at Amgen

Execute Quality disposition of bulk drug substances

Provide Quality oversight for clinical and commercial drug substance operations

Ensure deviations, quality events, and proposed changes are appropriately identified, assessed, documented, and managed

Ensure production records, testing results, facilities, equipment, materials, processes, and procedures comply with cGMP requirements

Collaborate cross-functionally to ensure Quality Management System processes are effectively executed

Champion continuous improvement initiatives

Complete all required training and maintain training compliance

Support internal and external audits and regulatory inspections

Amgen