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Kelly Services Engineer/Scientist I, Raw Material QC, Fremont, CA in Fremont, California

Engineer/Scientist I, Raw Material QC, Fremont, CA

Engineer/Scientist will use Standard Operating Procedures SOP and Good Manufacturing Practices GMP to will perform routine testing of raw materials .

Be responsible for multiple aspects of laboratory operations, such as sample receipt, data generation, material testing, data analysis and summarization, out-of-specification investigations, instrument qualifications, and other QC lab supporting activities.

What will you do?

  • Perform routine testing and analysis of raw materials according to established Quality Control procedures using different instrument platforms.

  • Document test results, complete batch records, document problems and other relevant information under cGMPs.

  • Maintain and analyze lot histories for trends and discrepancies.

  • Perform initial review on departmental paperwork; completed batch records.

  • Perform initial troubleshooting of issues which arise during routine analysis, perform out of specification OOS investigations and if needed, initiate non-conformance NCAR reports. Initiate OOS, NCARs and Variances, as required.

  • Perform initial troubleshooting of issues which arise during routine analysis under the direction of the Supervisor and Technical Operations.

  • Document test results, problems and other relevant information under cGMPs.

  • Perform simple procedure and worksheet revisions, as necessary.

  • Participate in departmental meetings.

  • Maintain laboratory space and participate in lab clean ups.

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

  • Keep department lead or supervisors updated on all issues.

How will you get here?

  • Minimum BS/BA in Chemistry, Biochemistry, or Bioscience with 0-2 yrs

  • Quality Assurance/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 and verbal communication skills.

  • Ability to follow written and verbal directions with a high level of accuracy.

  • Must be able to write clear, understandable documentation.

  • Manual dexterity must be able to lift/move up to 20 pounds.

  • Must be detail oriented and perform the work at a consistent level.

  • Intermediate word processing and spreadsheet software skills.

  • Strong organizational skills to be able to manage priorities and multiple tasks simultaneously.

  • 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.

  • Working knowledge of clinical analyzers is a plus.

Why Kelly ® ?

Kelly® Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

About Kelly ®

At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (