QA Specialist 1

@ Sigma-Aldrich Company Limited

QA Specialist

Your Role:

We have an exciting QA Specialist position within our Irvine site. In this role, you will lead customer, regulatory, and internal audit processes, overseeing preparation, management, and final closure. You will facilitate proactive audit preparation activities with cross-functional teams, identifying and resolving risks to product quality and compliance.

As a Subject Matter Expert (SME) in Quality Assurance, you will represent our department both internally and with external customers. Your responsibilities will include developing procedures and delivering engaging onboarding and training programs related to GMP to meet regulatory requirements.

You will also be expected to identify and lead Continuous Improvement initiatives, enhancing product quality and process efficiencies to ensure the highest levels of customer satisfaction.

Who You Are:

• Bachelor’s or Master’s degree in biological, life, or chemical sciences.
• Minimum five years of practical experience in Quality Management Systems.
• At least 2 years experience in a GMP environment.
• Experience with Veeva Vault is advantageous.
• Working knowledge of ISO 9001:2015 and EXCiPACT required.
• Knowledge of cell culture products is preferred but not essential.

Key skills/competency

• QA
• Audit
• GMP
• Continuous Improvement
• Training
• Compliance
• ISO 9001
• Risk Management
• Veeva Vault
• Life Sciences