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Engineer Scientist I / QC in Fremont, CA at Integrated Resources, Inc

Date Posted: 12/6/2018

Job Snapshot

Job Description

Job Description Position Summary: Using (SOP) standard operating procedures and (GMP) good manufacturing practices, the Chemist will perform routine testing of raw materials, work-in-process materials, finished goods kits, and filled bottle components. The QC Engineer/Scientist I will be responsible for all aspects of laboratory operations, such as sample receipt, data generation, product verification, data analysis and summarization, out-of-specification investigations, instrument qualifications, and all other QC lab supporting activities. Major Responsibilities: * Conducts analytical and functional testing of raw materials, intermediates, finished goods kits and/or filled bottle reagents/calibrators according to approved SOPs. * Perform testing using chemistry clinical analyzers and document accurate test results using spreadsheets and workbooks. * Performs initial troubleshooting of issues which arise during routine analysis, perform out of specification OOS investigations and if needed, initiate non-conformance NCAR reports. * Documents test results, complete batch records, document problems and other relevant information under cGMPs. * Performs simple revisions and updates to SOPs as necessary and initiate procedure change orders. * Summarize test data, maintain lot histories and analyze data for trends and discrepancies. * Maintain and order lab supplies as needed, and participate in lab clean ups. * Participates in interdepartmental and team meetings. * Performs other responsibilities to support the needs of the department as assigned by Supervisor. Minimum Requirements/Qualifications: * Minimum BS/BA in Chemistry, Biochemistry, or Bioscience with 0-2 yrs Quality Control experience, preferably in the medical diagnostics industry. * Strong laboratory skills including pipetting, safety, and hazardous chemical handling. * Understanding of cGMP and how it applies to the work environment is preferred. * High level of reading comprehension skills. * Ability to follow written and verbal directions with a high level of accuracy. * Must be able to write clear, understandable documentation. * High level of verbal communication skills. * Manual dexterity, must be able to lift/move up to 20 pounds. * Intermediate word processing and spreadsheet software skills. * Ability to manage multiple tasks simultaneously. * Ability to work independently. * Ability to perform simple data analysis and to summarize results. * Basic math skills including calculation of concentrations and dilutions and a strong grasp of algebraic concepts.