Person, Clinic, Hospital, Lab, Operating Theatre, Doctor

Quality Control Supervisor II

Quality Control Supervisor II

  • 2021-25861
  • Irvine, California, United States

Overview:

Provides leadership and direction in quality control. Develops and implements programs for product testing, trend analysis, compliance with Good Manufacturing Practice/Good Laboratory Practice (GMP/GLP) in support of facility-wide compliance and product quality goals. These might include ISO and other quality initiative implementation. Plans and executes staff strategies to assure on-time completion of testing. Responsible for release of highly regulated and critical products.

Responsibilities

Responsibilities:

  • Supervises workers engaged in raw material inspection and product testing activities.
  • Monitors daily operations and reviews QC test data.
  • Monitors the daily back order report and re-prioritizes batches appropriately.
  • Formulates, documents and maintains quality control standards and on-going control objectives.
  • Communicates, collaborates, and coordinates with Production and Planning departments to ensure timely testing and release of materials.
  • Oversees the Out of Specification (OOS) and Out of Tolerance (OOT) module for QC test results.
  • Develops and analyzes statistical data and product specification to determine QC standards.
  • Develops Installation Qualification (IQ), Operation Qualification (OQ), and Performance Qualification (PQ) validation plans and reports.
  • Responsible for the stability programs.
  • Maintains historical data trending for raw materials and finished goods.
  • Actively participates on continuous improvement teams.
  • Provides advanced troubleshooting assistance and training.

Qualifications

Qualifications:

  • Bachelor’s degree or equivalent in a related field.
  • 6+ year’s quality control or manufacturing experience.
  • 3-5 years of supervisory experience.
  • Strong communication, public-speaking, decision-making, MS Office, and negotiation skills.
  • Strong technical and analytical skills required.
  • Strong customer orientation and focus.
  • Familiarity with SAP or similar ERP systems a plus.
  • Understanding of ISO 13485, FDA regulations, GMP and GLP required.

 

 

Vaccination Requirement: 

 

Due to the higher threat of more infectious and deadly COVID-19 variant strains emerging, Bio-Rad recently announced a new mandatory vaccination policy requiring its US employees to be fully vaccinated against COVID-19 as a condition of employment. Bio-Rad will make reasonable accommodations for valid exemptions based on disability, medical, or religious reasons. With this policy, Bio-Rad joins a growing list of companies that are prioritizing sound science and available facts to best ensure the ongoing safety of its employees and the community.

 

 

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

 

 

Agency Non-Solicitation: 

 

Bio-Rad does not accept agency resumes, unless the agency has been authorized by a Bio-Rad Recruiting 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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