Specialist QC I

System Owner – F&E Technical Services – QC Equipment Support

Overview:

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 Computerised 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 Specialist will act as senior member of 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 for QC laboratory systems
• Conduct periodic reviews of instrument validation as part of validation life cycle.
• Manage laboratory equipment replacement through Lifecycle management programmes.
• Support Safety related investigations relating to laboratory equipment.

Equipment Maintanence

• Develop and own maintanence and calibration programmes for QC laboratory equipment.
• Perform assessment / review of pharmacopeia updates for impacts to maintenance programmes.
• Planning and conducting routine calibration, requalification and maintenance of laboratory equipment and ensure calibration and maintenance schedules are adhered to as per CMMS Maximo.
• Coordination of equipment repairs and maintenance with vendors/contractors and also carrying out equipment maintenance as required to minimize level of down-time for laboratory equipment, and disruption to laboratory activities.
• Lead programmes to improve equipment performance and reliability.
• Alerting Quality Control Management in the event of equipment failing to meet calibration or qualification requirements and conducting impact assessments/investigations as required.
• Serving as the point of contact with laboratory equipment vendors and engineers.
• Reviewing & filing of QC calibration & maintenance documentation.
• Coordinating the audit of new vendors with Amgen Global.
• Supporting deviations & investigations relating to equipment.

Quality

• Recognised as QC Equipment System Owner & Business Owner.
• Defend Amgen’s Laboratory systems validation, maintanence and data integrity philosophy in an Audit situation.
• Contribute to a culture of CI (continuous improvement)
• Participation in technical project teams as a subject matter expert on instrument validation regulations and procedures.
• Participate in technical project teams to support Global/ Enterprise System Lifecycle management.
• Support laboratory investigations and deviations.
• Any other tasks/projects assigned as per manager’s request.

Knowledge and Experience:

• Bachelor’s degree in a Science related field is required. 
• Minimum of 5+ years of laboratory experience in a cGXP laboratory environment including exposure to analytical instrument validation.
• Detailed knowledge of the methodology and instrumentation and analytical techniques used for biopharmaceutical testing.
• Understanding of current regulatory requirements for cGXP laboratory equipment validation and electronic record integrity.
• Demonstrated success in managing an equipment qualification or maintenance program advantageous.
• Key Amgen Values: Ensure Quality, Team Work, Be Science Based, Collaborate, Communicate, Be Accountable.