AS & T Principal Analyst - Aspex

Novartis Pharmaceuticals Fort Worth , TX 76102

Posted 5 months ago

Job Description:

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.

  • Plan and execute testing schedules with no supervision; coordinates daily workflow needs of the lab; Acts as a Supervisor designee (all issues excluding personnel matters)
  • Recognize lab supply needs and facilitates ordering

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

Employment Type

Regular


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AS & T Principal Analyst - Aspex

Novartis Pharmaceuticals