• Providing Quality Review/Oversight of site GMP documentation related to the operation of a vaccine manufacturing facility to ensure compliance with global regulatory agencies and quality standards.
• Performs testing including, but not limited to clinical and/or commercial product, raw materials and validation samples.
• Displays strong investigative or technological orientation with independence for design of projects/studies.
• Organizes and provides written and/or oral presentations of work with minimal input.
• Analyzes and interprets results, makes decisions regarding the accuracy, completeness and compliance.
• Responsible for final authorization/approval/release of documentation/equipment/processes.
• Assessing existing situations and suggesting improvements in the Quality systems to increase compliance throughout the facility
• Plans and leads projects to ensure their timely completion.
• Provide guidance/coaching to junior colleagues.