QC Instrumentation Senior Specialist
We are seeking a highly experienced QC Shared Services Instrumentation Senior Specialist to oversee the purchase, installation, qualification and lifecycle management of laboratory instruments. Reporting to the QC Instrumentation Team Lead, this specialist will be responsible for providing an Instrument Calibration and Maintenance service to the QC laboratory teams.
The ideal candidate will have strong experience in all aspects of instrument management in a GMP environment, including an understanding of routine biopharmaceutical drug product and drug substance laboratories. They will be responsible for establishing project plans and instrument qualification procedures.
Key Responsibilities:
* Providing a Calibration and/or Maintenance Service to the QC laboratory, including instrumentation calibrations, scheduling and tracking of instrument maintenance and instrument lifecycle management.
* Reviewing and approving analytical instrumentation qualification, calibration, repairs and documentation.
* Ensuring instrument maintenance and verification is appropriate to the use of the instrument.
* Managing all instrument specific investigations such as calibration deviations.
* Trending lab instrument performance and lifecycle management.
* Participating in new instrument purchase and qualification.
* Collaborating with a team of QC Specialists, QA validation Specialists and Computer System Validation personnel to deliver on the qualification of new instruments.
* Liaising with sister sites and vendors on instrumentation purchase, qualification and lifecycle management.
* E nsuring compliance with corporate policies, directives and current regulatory requirements for laboratory instrument qualification, calibration and lifecycle management.
* Contributing to the definition and establishment of instrument related procedures.
Requirements:
* A minimum of a B.Sc. in a scientific related discipline.
* At least 3 years' experience, with at least 1 year related to instrument qualification experience in a GMP laboratory setting.
* Previous experience in technology transfers would be advantageous.
* Demonstrated time management and organisational skills, with excellent communication essential.
Estimated Salary: $120,000 - $180,000 per annum