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, Change Controls, and Annual Product Reviews.
Lead and support deviation and investigation activities using structured root cause analysis tools and drive continuous improvement by identifying trends, system gaps, and opportunities to strengthen QC processes.
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
cGMP Quality Control
quality systems
technical expertise
QC documentation
investigations
regulatory requirements
Nice-to-have
structured root cause analysis
continuous improvement
cross-functional teams
flexible
resilient
results-driven
Key Requirements
Degree in Science or similar
Proven experience in cGMP Quality Control
Strong technical writing capability
Demonstrated analytical thinking
Proficiency with Microsoft Office and quality-related electronic systems