Senior Laboratory Equipment Specialist
6 days ago
The Senior Quality Control Associate will be responsible for coordinating the qualification, calibration, and routine maintenance of laboratory systems in a regulated environment.
- Developing and implementing calibration, requalification, and maintenance schedules to ensure compliance with regulatory requirements.
- Reviewing and filing quality control calibration and maintenance documentation.
- Planning, executing, and documenting the qualification of new laboratory equipment, including writing validation protocols and summary reports.
- Conducting periodic reviews of instrument validation as part of the validation lifecycle.
- Notifying management in the event of equipment failure to meet calibration or qualification requirements and conducting impact assessments/investigations as required.
- Scheduling and coordinating equipment repairs and maintenance with vendors/contractors, minimizing downtime and disruption to laboratory activities.
- Participating in technical project teams to provide expertise on instrument validation regulations and procedures.
- Managing change controls and adherence to Change Control metrics where applicable.
- Supporting the addition of project components to Maximo.
- Contributing to Data Integrity Assessments for Lab systems.
- Bachelor's degree in a Science related field is required.
- Minimum of 3 years of laboratory experience in a regulated laboratory environment, including exposure to analytical instrument validation and data integrity assessments.
- Detailed knowledge of methodology, instrumentation, and analytical techniques used for biopharmaceutical testing.
- Understanding of current regulatory requirements for laboratory equipment validation and electronic record integrity.
- Experience managing an equipment qualification or maintenance program is advantageous.
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