SeniorAssociate-QCTechnicalServices

## **Career Category** Quality ## ## **Job Description** **Level 4 -** Job Description - **Amgen Dun Laoghaire - Dublin** **System Owner – F &E Senior Associate – QC Equipment Support** **Overview:** Supporting the technical services team, the Senior Associate is responsible for planning, executing and documenting the qualification, calibration and routine maintenance of laboratory systems for cGMP Quality Control laboratory facilities at Amgen Dun Laoghaire. Responsible for managing & coordinating the schedules of Calibration Technicians & ensuring that all maintenance & calibration activities are tracked & managed through the Computerized Maintenance Management System (CMMS) Maximo. Responsible for authoring/owning and approving Validation Life Cycle documents for computer related systems including responsibility for Data Integrity testing and business administration of Laboratory Computer Related systems. The Senior Associate will act as system owner in the technical services team and will contribute to team training and mentoring. **Key Responsibilities** Supporting the Quality Control Laboratories, the System Owner is responsible for the complete life cycle of QC equipment. Responsibilities include Equipment Lifecyle management * Select and procure laboratory equipment in accordance with Amgen requirements. * Owns and project manages change controls and adhere to Change Control metrics. * Planning, executing and documenting the qualification of new laboratory equipment in a cGxP regulated environment. * Developing and maintaining an equipment qualification project plan, requirements, qualification protocols and summary reports as part of the commissioning of new laboratory equipment. * Generation and resolution of protocol deviations as required. * Writing/contributing to equipment operating procedures and manuals. * Designing and conducting training for QC staff, and other department staff as applicable. * Developing and maintaining Data Integrity Assessments