
Technical Specialist in Laboratory Operations
2 weeks ago
As a Sr QC Associate in Technical Services, you will be responsible for ensuring the accuracy and reliability of laboratory equipment.
- Plan and conduct routine calibration, requalification and maintenance of laboratory equipment to ensure schedules are adhered to.
- Review and file QC calibration and maintenance documentation to maintain compliance with regulatory requirements.
- Qualify new laboratory equipment in a cGMP regulated environment, including writing protocols and associated summary reports.
- Conduct periodic reviews of instrument validation as part of the validation life cycle.
- Alert Quality Control Management if equipment fails to meet calibration or qualification requirements.
- Bachelor's degree in a Science related field is required.
- Minimum of 3 years of laboratory experience in a cGMP laboratory environment.
- Detailed knowledge of analytical instrument validation and data integrity assessments.
- Understanding of current regulatory requirements for cGMP laboratory equipment validation and electronic record integrity.
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