Your Role:
An exciting opportunity has arisen for an experienced QA Supervisor to join the team in Irvine as a core member of the Quality leadership team, reporting to the site Head of Quality. In your role as QA Supervisor, you will be responsible for leading a team of 8 direct reports who handle a variety of tasks, including the approval of Batch Manufacturing Records, creation of label templates, maintenance of SAP master data (including inspection plans and Certificate of Analysis profiles), implementation of the site Change Control management processes, and implementation of the electronic document management system. You will also be expected to identify and lead Continuous Improvement initiatives related to the overall quality of products and process efficiencies.
Who You Are:
1. Bachelor’s or Master’s degree, preferably in one of the biological, life, or chemical sciences.
2. Minimum five years of practical experience working within Quality Management Systems in a similar role within a GMP environment is essential, complemented by associated Quality Assurance knowledge.
3. Minimum two years of QA Supervisory experience with a proven leadership track record.
4. Working knowledge of ISO 9001:2015, IPEC or EXCiPACT, EU Guidance on Good Manufacturing Practice (Orange Guide), EP/USP, aseptic processing, and change management preferred.
5. Excellent communicator with a high level of attention to detail.
6. Knowledge of cell culture products and their applications is preferred but not essential.
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