Associate Qc Scientist - Stevenage, United Kingdom - Autolus Ltd

Autolus Ltd
Autolus Ltd
Verified Company
Stevenage, United Kingdom

3 weeks ago

Tom O´Connor

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Tom O´Connor

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Description
Quality Control Operations manages and executes all routine testing using validated analytical methods and following prescribed testing plans.

Test results allow to monitor and drive the manufacturing processes, release the product or material, determine shelf life of the product or material and assess potency, quantity, identity and safety against defined specifications.


The role of Associate QC Scientist (Operations) is 90% lab based and involves performing in process analytical methods and reviewing data, equipment maintenance, laboratory housekeeping.

Please note these roles are specifically supporting our Warehouse operations and will not be on shift. Working hours will be Monday to Friday, 9am to 5pm (with flexibility required around working hours). However please note this could change in the future as Autolus grows.


Some of the responsibilities include:

  • Execution of analytical tests in process drug product samples
  • Laboratory housekeeping maintenance of laboratory in inspection ready state
  • Reagent preparation (e.g., preparation of media, aliquots, controls)
  • Management of QC materials (e.g., media preparation, aliquoting, stock management)
  • Operation and maintenance of analytical instruments in accordance to governing SOPs
  • Conducting basic root cause analysis (e.g., 5why's)
  • Initiation of deviation, laboratory investigation as required
  • Performing impact assessment for minor deviations
  • Data entry / collation for tracking and trending purposes
  • Archiving of GMP records
  • Completion of GMP documentation in accordance with ALCOA/data integrity requirements
  • Designing GMP documentation (e.g., logbooks, forms)
  • Managing GMP documentation (logbooks, worksheets, documentation trackers)
  • Timely completion of own quality events
  • Any other duties as required following consultation with the post holder
  • Work in adherence to local Health and Safety policies and SOPs
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