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Quality Control Supervisor II

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Quality Control Supervisor II

  • 2021-24653
  • Woodinville, Washington, United States

This position supports the manufacture of BioPlex commercial products with an emphasis on in-process and product release testing.  Specific duties include reviewing BioPlex QC MBR's, QC data anaylysis/troubleshooting, management of QC schedule and operators including ongoing/new employee training.  Responsible to ensure BioPlex QC operates according to SOP's and TM's employing Good Laboratory Practices in compliance with FDA/ISO regulations.

Responsibilities

  • Schedule and Manage employees to complete required testing. Ensure on-time testing, assay validity and data review. Review batch records to ensure compliance.
  • Set objectives for staff, monitor individual and team performance, coach employees to improve team performance and ensure compliance.
  • Participate in cross-functional teams such as MRB, QRB, CAR and scheduling meetings as needed.
  • Ensure lab compliance with safety regulations and GMP/GLP, including equipment validation, calibration and maintenance requirements.
  • Prepare and monitor department budget, including long term planning for personnel, equipment and other expenditures as needed.
  • Track critical QC data, monitor for trends and report to management.
  • Evaluate QC processes using Lean Six Sigma methods, revise as needed, to ensure compliance, maintain process control and eliminate waste.

Qualifications

Education:  Bachelor's degree or equivalent in Life Science, Chemistry, Biochemistry or related field.

 

Experience:  6+ years quality control or manufacturing experience.  3 - 5 years of supervisory experience.

 

Skills:

-Knowledge of BioPlex assays and experience collecting, analyzing and reporting on data preferred.

-Knowledge of Lean Six Sigma methods.

-Computer skills in relevant applications including Excel, Word, Visio and SAP.

-Requires strong communication skills and ability to work cooperatively and professionally with cross-functional teams.

-Requires strong analytical skills.

 

About Bio-Rad:

Bio-Rad is a global leader providing a broad array of clinical diagnostics and life science research products. With a team of more than 8,000 employees and a global network of operations serving our customers, we help people live longer, healthier lives.

Bio-Rad was founded over six decades ago and has continued to provide the healthcare industry with innovative and useful products that help life science researchers accelerate the discovery process and medical diagnostic labs obtain faster, better results.

 

EEO/AA Employer/Veterans/Disabled/Race/Ethnicity/Gender/Age

To all recruitment agencies: Bio-Rad does not accept agency resumes, unless the agency has been authorized by a Bio-Rad Staffing Representative. Please do not submit resumes unless authorized to do so. Bio-Rad will not pay for any fees related to unsolicited resumes.

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