Materials Inspection Specialist

4 weeks ago


Stevenage, Hertfordshire, United Kingdom Autolus Limited Full time
Quality Control manages and oversees the routine inspection, sampling and testing of all incoming materials for production use. This includes a wide variety of materials which are critical for the successful manufacture of the product and delivering a safe treatment for the patients.

Key Responsibilities:

* Inspection of incoming materials by confirming specifications and conducting visual inspection in accordance to procedures and internal specifications.
* Maintaining detailed records of sampling and inspection activities.
* Preparation of samples for chemical and microbiological (where required) analysis and delivering them to the QC lab.
* Assigning and verifying expiry dates for the raw materials through vendor CoA and/or in-house specification documents.
* Coordination and collaboration with warehouse team (e.g., pick of materials/samples, internal and external materials/samples transfers and shipments).
* Management of non-conformances.
* Compliance of warehouse areas in terms of isolation of quarantine, released and rejected raw materials
* Supporting QMS activities as required (OOS, CAPA, and change controls), to facilitate testing, qualification, system improvements and compliance.
* Working with other departments to plan and prioritise the inspection and release of materials.
* Ensuring compliance with local SOPs, policies and protocols Forms.
* Supporting documentation management.
* Drafting of SOPs and reports.
* Operating in compliance of cGMP.
* Any other duties as required following consultation with the post holder.
* Work in adherence to local Health and Safety policies and SOPs.

Demonstrated skills and competencies:

* E – Essential
* P – Preferred

Experience:

* Minimum 1 year experience on inspection of raw materials in a GMP environment (P)

Qualifications:

* 5 GCSEs including English, Maths and Science (E)

Skills/Specialist knowledge:

* Soft skills (effective written and spoken communication, organisation, teamwork) (E)
* Ability to precisely follow instructions and procedures (E)
* Attention to detail (E)
* Ability to use Office 365 tools (design of basic spreadsheets, tables, documents) (P)
* General awareness of different regulatory frameworks (e.g., EudraLex, ICH, FDA) (P)
* Basic understanding of GMP principles as applied to QC (E)
* Understanding the operation of QC laboratory (P)
* Working knowledge of Quality Management System records (e.g., deviation, CAPA, laboratory investigation, change control) (P)
* Experience in LIMS (P)


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