Quality Control Specialist

2 months ago

Stevenage, Hertfordshire, United Kingdom Autolus Limited Full time
Job Summary

As a Quality Control Specialist at Autolus Limited, you will play a critical role in ensuring the quality and safety of our products. This position involves managing and overseeing the routine inspection, sampling, and testing of all incoming materials for production use.

Key Responsibilities
  • Inspection and Sampling: Conduct thorough inspections of incoming materials to confirm specifications and ensure compliance with procedures and internal specifications.
  • Record Keeping: Maintain accurate and detailed records of sampling and inspection activities.
  • Sample Preparation: Prepare samples for chemical and microbiological analysis and deliver them to the QC laboratory.
  • Expiry Date Management: Assign and verify expiry dates for raw materials through vendor CoA and/or in-house specification documents.
  • Warehouse Coordination: Coordinate and collaborate with the warehouse team to ensure the efficient movement of materials and samples.
  • Non-Conformance Management: Manage non-conformances and ensure compliance with warehouse areas in terms of isolation of quarantine, released, and rejected raw materials.
  • Quality Management System: Support QMS activities, including OOS, CAPA, and change controls, to facilitate testing, qualification, system improvements, and compliance.
  • Collaboration and Communication: Work with other departments to plan and prioritize the inspection and release of materials, ensuring compliance with local SOPs, policies, and protocols.
  • Documentation Management: Support documentation management and drafting of SOPs and reports.
  • Compliance: Operate in compliance with cGMP and local Health and Safety policies and SOPs.
Requirements
  • Experience: Minimum 1 year experience in inspection of raw materials in a GMP environment.
  • Qualifications: 5 GCSEs including English, Maths, and Science.
  • Skills: Soft skills (effective written and spoken communication, organization, teamwork), ability to precisely follow instructions and procedures, attention to detail, and basic understanding of GMP principles as applied to QC.

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