QC Instrumentation Specialist

QC Instrumentation Senior Specialist

Our client a leading biologics manufacturer is seeking a QC Instrumentation Specialist to oversee the procurement, installation, qualification, and lifecycle management of laboratory instrumentation. Reporting to the QC Instrumentation Team Lead, this role involves managing the calibration and maintenance services for QC laboratory instruments.

Key Responsibilities:

• Provide calibration and maintenance services for QC laboratory instruments, including scheduling and tracking.
• Review and approve documentation related to instrument qualification, calibration, and repairs.
• Ensure maintenance and verification processes align with instrument use.
• Manage investigations related to instrument calibration deviations.
• Monitor and manage instrument performance and lifecycle.
• Participate in the selection and qualification of new instruments.
• Collaborate with QC specialists, QA validation specialists, and Computer System Validation personnel to qualify new instruments.
• Liaise with sister sites and vendors regarding instrument procurement, qualification, and lifecycle management.
• Ensure compliance with corporate policies and regulatory requirements for instrument qualification, calibration, and lifecycle management.
• Develop and establish procedures related to instrumentation.
• Troubleshoot complex instrumentation issues.

Qualifications and Skills:

• Minimum B.Sc. in a scientific discipline
• At least 3 years' experience in a GMP laboratory setting, with at least 1 year focused on instrument qualification
• Experience with data integrity management (21 CFR 11/EU Annex 11) is preferred.
• Fundamental understanding of protein biochemistry is desirable
• Technical expertise in Biopharmaceutical analytical platforms such as HPLC/UPLC, CE, cIEF, SDS-PAGE, Biacore, HIAC, KF, and Liquid Handlers
• Experience with technology transfers is advantageous
• Strong team collaboration skills and the ability to lead
• Excellent time management, organisational skills, and communication abilities