#x 9; Conducts analytical and functional testing of components and finished product according to approved SOPs Perform testing using typical laboratory instrumentation, including chemistry clinical analyzers, and document test results accurately using Excel spreadsheets and workbooks. Documents test results, complete batch records, document problems and other relevant information under cGMPs. Perform simple revisions and updates to Q - Cs SOPs and/or worksheets as necessary, and initiate procedu... more details
Location: Fremont, CA Pay rate: $28 per hour Contract Length:12-months with possibilty to convert
Job Description: Using standard operating procedures (SOP) and good manufacturing practices (GMP), the QC Engineer/Scientist I will perform testing of components and finished products as part of the product release process. The QC Engineer/Scientist I will be responsible for all aspects of laboratory testing, such as sample receipt, data generation, data analysis and summarization, instrument operation, and other QC lab supporting activities.
Responsibilities:
Conducts analytical and functional testing of components and finished product according to approved SOPs
Perform testing using typical laboratory instrumentation, including chemistry clinical analyzers, and document test results accurately using Excel spreadsheets and workbooks.
Documents test results, complete batch records, document problems and other relevant information under cGMPs.
Perform simple revisions and updates to QCs SOPs and/or worksheets as necessary, and initiate procedure change orders.
Summarize test data, maintain lot histories and evaluate data for trends and discrepancies.
Performs other responsibilities to support the needs of the department as assigned by Supervisor.
Participate in PPI, Lean, and 5S programs, as required.
Minimum Requirements/Qualifications:
Minimum BS/BA in Chemistry, Biochemistry, or Bioscience with 0-2 yrs Quality Assurance/Quality Control experience, preferably in the medical diagnostics industry.
Demonstrated ability and/or additional experience may be considered in lieu of a BS/BA degree.
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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