QC Supervisor/Manager

Job Location
San Jose, CA
Job Description

Click Diagnostics is an early stage biotech startup that is looking to hire a QC Supervisor/Manager to the QA team. This ambitious and fast-paced company is taking an innovative approach to medical diagnostic tests. This position reports to the Director of Quality and Regulatory.

Scope of Position

The QC Supervisor/Manager is an enthusiastic, self-motivated individual with great communication skills who can support the development and management of the Quality Control laboratory compliant with ISO 13485 and FDA QSR. The QC Supervisor/Manager will demonstrate a high level of individual responsibility and accountability. 

  • Creating, updating, reviewing and developing QC laboratory standard operating procedures and supporting work instructions in compliance with ISO 13485 and FDA QSR
  • Plan, organize, and supervise the daily work schedule to support production
  • Aid in the development and implementation of inspection procedures
  • Write and perform QC method qualification, verification/validation protocols
  • Performs environmental monitoring of utilities and facilities
  • Complete investigations for Out of Specification (OOS), CAPA, deviations, and perform trending
  • Maintain accurate personnel, training, and inspection records
  • Maintain a safe, organized, and clean work environment
  • BS in science or engineering required;  Microbiology, Chemistry, or related discipline a plus; MS or PhD preferred
  • Minimum 5 years of laboratory experience; supervisory experience a plus

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