Chek Diagnostics, a medical diagnostic device manufacturer, is hiring a Manufacturing Chemist II in Sunnyvale, CA.
• Are you a skilled, hands-on chemist interested in creating new products that can help save lives?
• Do you enjoy research and the innovative process?
• And, would you thrive in an entrepreneurial, energetic company that is experiencing consistent growth?
At Chek Diagnostics, we take great pride in delivering industry-leading point-of-care and home diagnostics to the global health care market. Our focus is the development of diagnostic tests for chronic diseases such as heart disease, diabetes, and other related medical conditions.
With 30% annual growth and strong profitability, we have committed to the ongoing development of innovative products for the early diagnosis and the ongoing management of these diseases; we take the business of supplying the highest quality, most technologically advanced tools possible very seriously. Founded in 1992, Chek Diagnostics is headquartered in Indianapolis, Indiana, USA. Our products are represented in more than 100 countries worldwide.
As our Manufacturing Chemist II you will be responsible for calibration manufacturing and testing, while supporting the transfer of new technology from R&D to Manufacturing. Reporting to the Calibration Supervisor, you will be responsible for supporting the calibration, operation and maintenance of any related production equipment when necessary. Remain alert to compliance situations with regulatory requirements of the Quality System documentation. Adopting a “quality in everything we do” approach, trained on all Quality System Work Instructions (WIs) and follow them when performing all job functions.
• Perform calibration testing which includes running Total Hb, A1C whole blood calibration, temperature calibration, accuracy bias, initial lot release for Pilots / ICA and finished products.
• Perform stability testing and characterize the meters as needed.
• Take lead in tracking the performance of the lots (metrics).
• Develop and revise procedures. Train new chemists and drive assigned projects as needed.
• Make detailed observations, analyzes data and interprets results.
• Maintains production materials in working order and use calibrated equipment at all the times.
• Regularly interact with R&D and identify process improvement opportunities in calibration.
• Ensure smooth transfer of new and improved processes to reagent manufacturing.
• BS/BA degree in Chemistry/Biochemistry /Biology or related scientific discipline.
• 3-5 years of experience in medical device or pharmaceutical industries.
• Knowledge of IVD technologies is a plus.
• Ability to use chemistry and biochemistry/biology laboratory techniques.
• Ability to follow written and verbal instructions & time management skills.
• Prepare technical reports, summaries, and protocols and perform quantitative analyses.
• Use methods for statistical experimental design and data analysis.
• Work well in a team situation with others, scientific and nonscientific is necessary on carrying out project team membership.
• Ability to function in a high impact position within a fast-paced, deadline driven environment.
• Strong problem-solving and communication skills to assess situations and drive decision-making.
• Able to work irregular and extended hours.
COMPENSATION AND BENEFITS:
Chek Diagnostics will reward your talents with a generous salary plus possible incentive opportunity. You will also receive a generous benefits package including medical benefits, dental, flexible medical spending account, life insurance, short–term and long-term disability, PTO, and 401(k) retirement plan with company match—100% up to 5%.
If you are a chemist who enjoys working on the cutting edge of innovation, we encourage you to apply online now.
To learn more about Chek Diagnostics, please visit www.cardiochek.com.
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