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Laboratory Quality Assurance Specialist
2 weeks ago
The successful candidate will be responsible for planning and executing routine calibration, requalification, and maintenance of laboratory equipment to ensure adherence to scheduled schedules.
- Review and file QC calibration and maintenance documentation.
- Qualify new laboratory equipment in a regulated environment, including writing validation protocols and summary reports.
- Conduct periodic reviews of instrument validation as part of the validation life cycle.
- Schedule and coordinate equipment repairs and maintenance with vendors to minimize downtime and disruption to laboratory activities.
- Participate in technical project teams to act as an expert on instrument validation regulations and procedures.
A bachelor's degree in a science-related field is required. A minimum of 3 years of laboratory experience in a cGMP laboratory environment, including analytical instrument validation and data integrity assessments, is also necessary.
- Detailed knowledge of biopharmaceutical testing methodologies, instrumentation, and analytical techniques.
- Understanding of current regulatory requirements for cGMP laboratory equipment validation and electronic record integrity.
