Quality Scientist 2
The Quality Scientist 2, in Quality Control performs analytical testing and assay validation in collaboration with R&D, QA and Manufacturing, assists in the analysis, review and release of QC data for the purpose of final product approvals and provides support for document revision, stability studies and process improvement efforts.
Working knowledge of AKTA/Unicorn, HPLC, PCR, DNA Sequencing, Fragment Analysis, and Applied Biosystem’s Capillary Electrophoresis equipment strongly desired. Also working knowledge of microplate assays, microplate luminometers, microplate fluorimeters is desired.
Viscosity, Fluorescence, Plate Robotics and a variety of HPLC experience (SEC, Ion Exchange, Reverse Phase – platforms Agilent Chemstation and PE) preferred. Knowledge of Process Excellence, Six Sigma and Lean Manufacturing is also a plus.
Summary of Essential Job Functions
· Conduct analytical testing used to control raw materials, production intermediates, and final products
· Maintain thorough and complete product test records per in-house testing procedures and in compliance with ISO9001, ISO13485, safety and regulatory requirements
· Track and expedite closure of deviations determining root cause and CAPA for nonconforming product
· Assist in the validation and transfer of new or existing analytical methods (chromatography, ELISA, viscosity, solids, fluorescence, etc.)
· Assist in writing and reviewing new and existing SOPs
· Manage in-house stability studies
· Requires a BS or higher in Chemistry (or equivalent), with 3-5 years of experience in a Biotech QC environment.
· Methods development, validation and technology transfer experience highly desired.
· Strong understanding of ISO 9001 requirements is essential, while cGMP experience is preferred.
· Must be able to work independently as well as work with a diverse team.
· Ability to prioritize assignments and to manage multiple projects in a time-sensitive environment is essential.
· Knowledge of SAP or similar inventory control systems desired.
· Familiar with Microsoft Excel and Word.
· Excellent oral and written communication skills are required to be effective in this role.
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