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.
• 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 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.
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