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Form of workJob Title : Quality Control
Location : Fremont, CA 94538 (Onsite)
Duration : 12 Months Contract
Shift: 8 am - 5pm M-F
Possibility for OT: Minimal
Position Summary:
Using standard operating procedures (SOP) and good manufacturing practices (GMP), the QC Engineer/Scientist I will perform testing of raw materials as part of the Incoming Material process, before they can be used to build filled components and finished goods kits. 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 raw materials 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.
Additional info:
• What is the reason this role is open: new position – increased work load
• Day – to -day: mostly lab based – expect them to testing material 60-80 % of the time – rest doing paperwork. Raw material testing.
• What is the dress code for this role? Business casual – lab attire – closed toed shows – long pants.
• Comfortable working with biological materials – testing can be done on blood and urine.
Location : Fremont, CA 94538 (Onsite)
Duration : 12 Months Contract
Shift: 8 am - 5pm M-F
Possibility for OT: Minimal
Position Summary:
Using standard operating procedures (SOP) and good manufacturing practices (GMP), the QC Engineer/Scientist I will perform testing of raw materials as part of the Incoming Material process, before they can be used to build filled components and finished goods kits. 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 raw materials 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.
Additional info:
• What is the reason this role is open: new position – increased work load
• Day – to -day: mostly lab based – expect them to testing material 60-80 % of the time – rest doing paperwork. Raw material testing.
• What is the dress code for this role? Business casual – lab attire – closed toed shows – long pants.
• Comfortable working with biological materials – testing can be done on blood and urine.
