|Reference # :||19-06710||Title :||Chemist|
|Location :||Fremont, CA|
|Position Type :||Contract|
|Experience Level :||Start Date / End Date :||06/06/2019 / 12/31/2019|
The Chemist 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.
* 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.