The Specialist, Quality Control is responsible for supporting Quality Control operations and quality systems to ensure compliance with company Global Quality standards, regulatory requirements, and current Good Manufacturing Practices (cGMP)
Job Summary
The Specialist, Quality Control is responsible for supporting Quality Control operations and quality systems to ensure compliance with company Global Quality standards, regulatory requirements, and current Good Manufacturing Practices (cGMP).
Author, review, approve, and provide technical oversight for QC GMP documentation, including but not limited to: Laboratory Investigations, Quality Notifications, CAPAs, SOPs, and Change Controls.
Lead and support deviation and investigation activities using structured root cause analysis tools and drive continuous improvement by identifying trends and system gaps.
Matching Summary
The Specialist, Quality Control is responsible for supporting Quality Control operations and quality systems to ensure compliance with company Global Quality standards, regulatory requirements, and current Good Manufacturing Practices (cGMP).
Skills & Requirements
Must-have
Quality Control operations and quality systems
cGMP compliance
QC documentation expertise
Technical writing capability
Structured problem-solving skills
Attention to detail and commitment to quality
Nice-to-have
Culture of quality and data integrity
Cross-functional team collaboration
Flexible and resilient approach
Key Requirements
Degree in Science or similar
Proven experience in cGMP Quality Control
Proficiency with Microsoft Office and quality-related electronic systems