Scientist I/II, QC CQV
wuxibiolog · Posted Jun 19, 2024
- Cranbury, New Jersey, United States
- Entry
- 2+ years
Responsible for qualification, validation, maintenance, and lifecycle management of QC laboratory instruments, computerized systems, and software applications in a GMP-regulated environment.
Responsibilities
- Develop and execute calibration, preventive maintenance, qualification, and repair activities for QC laboratory instruments
- Coordinate vendor service activities and collaborate with Facilities, Engineering, Validation, IT, and QC groups
- Review documentation to ensure compliance with GMP and site procedures
- Support equipment lifecycle management from acquisition to retirement
- Lead or support Installation, Operational, and Performance Qualification activities
Requirements
- Bachelor's degree in Biology, Chemistry, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, Computer Science, Engineering, or related scientific discipline
- Master's degree in related scientific discipline
- Nice to have: Experience with laboratory computerized systems
- Nice to have: Analytical instrumentation qualification
- Nice to have: Software administration