Quality Assurance Specialist

We're looking for a Quality Assurance (QA) Specialist to join our client's team. In this role, you would be playing a key part in maintaining quality and ensuring compliance across all site operations.

The QA Specialist will serve as a Subject Matter Expert (SME) for specific quality systems. You'll be responsible for driving continuous improvements, upholding regulatory standards, and embedding best practices throughout the business.

This position is ideal for a QA professional with 4-5 years of experience and solid knowledge of Deviation/CAPA, Change Control, Quality Risk Management (QRM), and Documentation Management systems. The ideal candidate will also have the ability to influence and collaborate effectively across various teams.

Key Responsibilities

• Provide oversight and help with continuous improvement for key site quality systems like Change Control, Deviation/CAPA, and Documentation Management.
• Support the management of Quality Risk Management (QRM) processes and help integrate QRM principles into quality frameworks.
• Contribute to and maintain the Quality Management Review process, ensuring it aligns with company policies.
• Assist with trending programs for quality systems and interpret data to help inform optimization strategies.
• Monitor regulatory changes to ensure site quality systems remain compliant and inspection-ready.
• Help with ongoing compliance initiatives, including self-inspections, internal audits, and continuous improvement activities.
• Contribute to the development and management of Quality Agreements relevant to your area of expertise.

Skills, Attributes & Experience

• Degree in Science, Engineering, or a related field.
• 4-5 years of experience in QA roles within the pharmaceutical or biotechnology industry.
• Experience with root cause analysis, investigations, and problem-solving.
• Strong understanding of regulatory expectations and inspection readiness.
• Excellent written and verbal communication skills.
• Proven ability to collaborate across different teams and influence stakeholders.