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PDS Tech Inc Engineer Scientist I / QC in Fremont, California

PDS Tech is seeking candidates for a Quality Control Chemist position in Fremont, CA

Position Summary:

Using Standard Operating Procedures (SOP) and Good Manufacturing Practices (GMP), the Chemist will perform routine testing of raw materials, work-in-process materials, finished goods kits, and filled bottle components, as well as stability testing of on-market products. The QC 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.

Key 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.

  • Perform stability testing protocols on new launched products and on market products.

  • Participate in daily standup meetings or scheduling meetings.

  • Performs initial troubleshooting of issues which arise during routine analysis, perform out of specification OOS investigations and initiate non-conformance NCAR reports if needed.

  • 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 for trends and discrepancies.

  • Maintain and order lab supplies as needed, and participate in lab clean ups.

  • Participates in cross functional department and team meetings.

  • Performs other responsibilities to support the needs of the department as assigned by Supervisor.

  • Participate in PPI, Lean, 5S programs

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.

All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.