
Laboratory Equipment Maintenance Specialist
2 days ago
A Quality Assurance Specialist is sought to oversee the calibration, qualification and maintenance of laboratory equipment in a cGMP regulated environment. This includes planning and executing validation protocols for computer-related systems, ensuring data integrity compliance and coordinating with vendors for equipment repairs.
Key Responsibilities:- Developing and implementing calibration schedules for laboratory equipment, reviewing and filing of related documentation.
- Authorizing and approving validation life cycle documents for new laboratory equipment, including writing equipment validation protocols and summary reports.
- Conducting regular reviews of instrument validation as part of the validation life cycle.
- Alerting management to equipment that fails to meet calibration or qualification requirements and conducting impact assessments/investigations as needed.
- Coordinating equipment repairs and maintenance with vendors/contractors to minimize downtime and disruption to laboratory activities.
- Participating in technical project teams as a subject matter expert on instrument validation regulations and procedures.
- Managing change controls and adhering to relevant metrics where applicable.
- Supporting and managing the addition of project components to CMMS Maximo.
- Contributing to Data Integrity Assessments for Lab systems.
- Bachelor's degree in a Life Science or related field.
- Experience in a cGMP quality control environment.
- Knowledge of instrument validation procedures and regulations.
- Excellent communication and organizational skills.
- A competitive salary and benefits package.
- The opportunity to work in a dynamic and collaborative team environment.
- Professional development and growth opportunities.
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Laboratory Equipment Specialist
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Laboratory Equipment Specialist
2 days ago
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