Quality Assurance Specialist

Seeking a Lab QC Specialist to perform testing on raw material, in-process products, and final products to ensure material quality as well as to perform tests for monitoring environmental conditions and water quality. Analyze and prepare reports of test results. Sample duties:Plan, develop and execute testing processesDevelop and execute testing methods for final and in-process products which includes: SDS PAGE for quantification and purity analysis, HPLC analysis, endotoxin, sterility, mycoplasma, host cell protein and residual DNA testingRevise standard operating procedures as necessaryCoordinating samples for outsourced testingDocumentation of all final products (Product Quality Control Profiles and management of data)Coordinating with other departments for sample submission Develop, validate, implement and run methods for HPLC analysisMaintain and record data clearly and preciselyREQUIREMENTS:BA/BS degree in Biology, Molecular Biology, Cell Biology, Chemistry, Biochemistry or equivalent2+ years in pharmaceutical, or biotech lab environments with an emphasis on testingGood Lab safety proceduresUnderstanding of 21CFR211 – cGMP, ISO 13485 and/or ISO 9001, material specifications, and related areas