QC Supervisor/Manager

Organization
ClickDX
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
Requirements
  • 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

Gladys Kong writes at Fortune that her STEM background has helped her as a CEO.

Social scientists report that the image of the 'lone scientist' might be deterring US students from STEM careers.

Postdocs supported by external funding are less likely to have access to paid parental leave, Nature News reports.

The US National Institutes of Health's new plan will bolster support for early- and mid-career investigators.