The role of the Senior Quality Control Specialist is to provide technical expertise and support for the Operational Support functions of the QC Laboratory.
Responsibilities:
Perform compendial assessments to ensure compliance with current regulatory requirements and pharmacopeia standards.
Author and review technical documents, including protocols, standard operating procedures (SOPs), and analytical methodologies.
Design and coordinate analytical method onboarding activities, including execution planning, training, and documentation.
Lead and manage the qualification of critical materials, analytical instrumentation and equipment, ensuring fitness for use in analytical testing.
Oversee change control management processes, including risk assessment, documentation, and implementati...