Click Diagnostics is an early stage biotech startup that is looking to hire a Associate Systems Engineer to its engineering 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
Skills, Experience, Education
- 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
- Salary, bonus, full benefits, company stock options
- Title is dependent on education and experience
Please e-mail your resume to firstname.lastname@example.org with the subject "QC Supervisor/Manager”.