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SalaryWe 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
