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Thermo Fisher Scientific · 3 hours ago

QC Scientist III

St Louis, MO

Full-time

Onsite

Mid, Senior Level

5+ years exp

Thermo Fisher Scientific is dedicated to making the world healthier, cleaner, and safer. As a QC Scientist III, you'll perform sophisticated analytical testing and provide quality oversight for biopharmaceutical products, ensuring product safety and compliance with regulatory requirements.

BioinformaticsBiotechnologyCloud Data ServicesConsultingHealth CareLife ScienceManagement Information SystemsOffice SuppliesPrecision Medicine

No H1B

Responsibilities

Conduct GMP testing in an analytical laboratory environment using Separation Techniques, BioAssay Analysis and Compendia test methods (i.e.,Reverse Phase, SEC, Titer concentration, iCE, pH, Osmolarity, Residual DNA, Appearance)

Help develop and build the foundation of a liquid chromatography technical team by implementing standard practices and policies

Perform testing on In-Process, DS release, DS stability, DP Stability, and various other non-routine samples, ensuring timely delivery for projects

Recognize and report out-of-specification/ out-of-trend results to laboratory management; recommend solutions

Participate in analytical method validation/transfer, method establishment/qualification routine and stability analysis

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

Perform all duties in compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices, and Safety guidelines

Participating in laboratory activities, including safety inspections and client audits

Communicate findings and discuss relevance of your data to a multi-discipline team consisting of upstream and downstream process development scientists, quality control, quality assurance, process engineers and our customers

Qualification

GMP pharmaceutical quality controlAnalytical techniquesMethod validationFDA regulationsData analysisTechnical writingMicrosoft Office SuiteProject managementInterpersonal skillsCommunication skillsProblem-solving skillsMentoring