QC Analyst – Biochemistry and Cell Biology

QC Analyst – Biochemistry and Cell Biology

• This role will be part of our Testing Self-Directed work team in our state of the art single use multiproduct biotech facility
• The organisational structure at the site will be based on self-directed work teams where decisions will be made at the level where the data exists.
• The Quality Control Analyst will work across the site self-directed work teams and hub teams to identify and resolve issues in order to allow the site to deliver on our commit culture that support Quality, EHS, Learning and Continuous improvement.
• The Quality Control Analyst will be responsible for functional testing of in-process drug substance/drug product, final and drug products, and stability samples at the new single use multiproduct biotech facility
• The overall responsibility for this role will be to support the Quality Control testing function related to Biochemistry and Cell Biology methods, ensuring compliance with cGMP and corporate regulations.

This is a critical role within the Quality organisation to help establish the Laboratories as a hub for specialised analytical testing and create value for our patients.

• Contribute to a team setting within the laboratory and project activities and with other teams to increase efficiency, solve problems, generate cost saving, improve quality and provide new product support

Key Accountabilities

Perform a variety of routine Biochemistry and Cell Biology analytical testing techniques and associated documentation; including but not limited to ELISA, PCR, Bioassays and Cell Culture,

Water and cleaning validation sample testing and compendial methods in compliance with GMP requirements.

• Review and approve Analytical Testing data.
• Support activities including general lab readiness, audit readiness, laboratory equipment qualification and analytical method technical transfer, verification and validation.

Degree in Science