Using in-depth knowledge of relevant guidance/regulatory documents, perform and lead routine and non-routine testing activities to include analytical method validations, analytical method transfers, product/process investigations, ensuring required quality and safety standards are being met for our products and processes.
Planning Ensure supplies and equipment are available to meet test schedules.
Technical To perform testing activities, ensuring required quality and safety standards are being met for our products.
Execute analytical method development and validation
Perform non-routine testing to support special projects
Execute analytical method transfers as the receiving lab and the transferring lab
Write/review/approve validation protocol and technical reports
Collect, calculate, interpret and trend results
Write SOPs related to testing programs, laboratory operations and/or equipment operation
Participate in root cause analysis; lead and write laboratory investigations
Perform and review equipment calibration and maintenance; instrument advocate and subject matter expert
Evaluate novel technology for laboratory/manufacturing application
Identify appropriate lab instrumentation purchases; perform qualification/validation
Conduct peer review and approval of data collected by co-workers
Lead lab initiatives or programs and train analysts
Perform statistical analysis
Utilize change control systems
Represent the laboratory as the Subject Matter Expert in all major test disciplines and processes
Track and report laboratory performance metrics
Team Cooperate and support co-workers to enhance overall capability the organization
Lead problem solving and troubleshooting of laboratory issues and methodology
Contributes to departmental meetings; provides technical insight and presentations
Team Leader/Supervisor Designee
Demonstrates overtime flexibility
Demonstrates Alcon/Novartis Values and Behaviors
Interfaces Coordinate/support other departments to ensure smooth execution of work.
Excellent communication both verbal and written skills concerning testing and sampling scheduling with other departments and external labs/vendors
Professional and skilled interface with auditors