QC Instrumentation Specialist
We are seeking a highly skilled QC Instrumentation Specialist to oversee the procurement, installation, qualification, and lifecycle management of laboratory instrumentation for our client, a leading biologics manufacturer.
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.
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
Estimated salary: $80,000 - $110,000 per annum