QC Scientist II

at  Thermo Fisher Scientific

JOB DESCRIPTION

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, ensuring our food is safe or helping find cures for cancer.

• Perform HPLC/UPLC testing on In-Process, DS release, DP release, DS stability, DP Stability, and various other non-routine samples, ensuring timely delivery for projects
• Participate in analytical method validation/transfer, method establishment/qualification routine and stability analysis.
• Conduct GMP testing in an analytical laboratory environment using HPLC and UPLC test methods (i.e.,Reverse Phase, SEC, Titer concentration, CEX, etc)
• Compiles data for documentation of test procedures, prepares reports. Ensures all testing processes, monitoring, and departmental documentation meet SOPs and cGMP regulatory standards.
• Participate in the development of new concepts, techniques, and standards. Involved with assisting in the preparation of CoAs.
• Recognize and report out-of-specification/ out-of-trend results to laboratory management; recommend solutions.
• Perform all duties in compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices, and Safety guidelines
• Partake in laboratory activities, including safety inspections and client audits in a timely matter.