QA Associate

We have a great opportunity available for a QA Associate to join our clients QA Operations team. This is a permanent position.

As a QA Associate 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:

  • Reviewing documentation generated during manufacturing processes and for ancillary areas of manufacturing, coordinating of review and any follow-up actions/corrections of GMP documentation.
  • Auditing documentation generated during development and laboratory processes, including protocols, assays/raw data and validation reports.
  • 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 preparation of the area for inspection readiness
    Advising operators on best practices 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