This is a 23-month contract.

Purpose

We are looking for a QC Instrumentation Specialist to join our growing team.

Growing your career as a Full Time QC Instrumentation Specialist is an amazing opportunity to develop exceptional skills, working with a wide range of analytical instruments across a wide range of laboratories.

If you are strong in adaptability, and critical thinking and have the right drive for the job, then apply for the position of QC Instrumentation Specialist. The successful candidate will plan, execute, and manage the activities required to maintain the testing infrastructure of the QC lab.

Responsibilities

The QC Instrumentation Specialist’s roles and responsibilities include but are not limited to the following:

Responsible for the qualification, maintenance, and/or integration of the QC systems, in compliance with up-to-date data integrity, regulatory, and industry standards.
Responsible for change control processes and mechanisms required to maintain a state of continuous compliance for the QC systems and instrumentation.
Be part of the team responsible for providing a Maintenance Service to the QC laboratory
Support the QC department for troubleshooting, investigations, and deviations as an SME.
Manage deviations, CAPA, and change controls related to the QC and team priorities.
Author and revise local SOPs, work instructions, and guidelines.
Serve as an SME for regulatory and internal inspections and audits.
Review and approve analytical instrumentation qualification, calibration, and repair documentation
Support new instrument qualifications and upgrades, where you would be part of the team that will generate, review and approve the IOQ/PQ documentation (GxP, URS, IOQ, ERES, PQ, RTM, ATR, SOP/WI)

Requirements

A bachelor’s degree in Engineering, biological science, or an Electrical qualification.
3 years experience which should be related to instrument qualification experience in a GMP laboratory setting
Working knowledge of biologics analytical methods and specifications and Good Manufacturing Practice (GMP).
Strong experience with analytical instrument qualification and maintenance
Excellent understanding of data integrity compliance requirements.
Ability to prioritize maintenance activities in line with the project schedules and business needs.
Ability to maintain the flexibility to react to changing business needs.
Ability to work in a team-based environment
Metrology/Calibration experience advantageous