Quality Specialist

About the role

The Quality Specialist will support the Quality Manager in driving quality assurance activities for Corning's Life Sciences site in Singapore. This role focuses on maintaining compliance with internal and external standards, managing documentation, and ensuring product release quality.

Key responsibilities

• Develop, update, and train staff on Standard Operating Procedures (SOPs).
• Review batch records and perform product release activities.
• Coordinate QC testing, sample submission, and result review.
• Manage calibration program and associated records.
• Lead quality documentation, non‑conformance reports, inspections, and product disposition.
• Collaborate with APAC Regulatory team on compliance and regulatory approvals.
• Conduct routine cleanroom monitoring, including airborne particle and differential pressure checks.
• Investigate and analyze quality issues to support resolution.
• Support customer audits and ensure adherence to company policies.

Required profile

Required skills

• Good Manufacturing Practices (GMP)
• 21 CFR 820 compliance
• ISO 9001 knowledge
• Quality System Procedures
• SOP creation and training
• Calibration program management
• Cleanroom monitoring techniques
• Batch record review
• Non‑conformance reporting
• Regulatory compliance coordination