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We have a great opportunity available for a QA Specialist – to join our QA Operations team, which is part of our Quality Assurance Department. This is a permanent position based out of our state-of-the-art Slough facility.

As a QA Associate – Batch Review you will be part of a team ensuring that quality is maintained at an appropriate level meeting customer and regulatory expectations and enabling the site to deliver to relevant targets.

Key Responsibilities:

• Auditing documentation generated during manufacturing processes and for ancillary areas of manufacturing, co-ordinating of review and any follow-up action or corrections of GMP documentation
• Auditing documentation generated from the Analytical Services, Purification Development and Quality Control departments
• Acting as a point of contact for general queries relating to quality and escalating as required
• Expand and utilise knowledge of quality procedures to identify and report non-conformances and resolve issues arising in the area via interaction with the relevant personnel
• Raw material release
• Ensure current GMP requirements for all areas are met
• Assist in the preparation of the area for inspection readiness
• Advising operators on best practises for document completion, review and follow-up actions or escalating if required

Key Requirements:

• BSc or equivalent in a biology-related field
• Experience working within QA ideally in a manufacturing environment with good knowledge of GMP.
• Working experience with Biologics.
• Great attention to detail
• Demonstration of workload prioritisation skills, decision-making and scheduling skills