Quality Specialist

Responsibilities

• Develop and support Quality Assurance activities, SOPs, and compliance for the Singapore site.
• Direct employee training, SOP creation, and continual process improvement objectives.
• Review batch records and perform product release activities.
• Coordinate QC testing, including sample submission and testing result review.
• Manage the calibration program and maintain accurate record keeping.
• Lead Quality Documentation, Nonconformance Reports, Inspection Activities, and Product Disposition.
• Perform routine cleanroom monitoring, including airborne particle monitoring and differential pressure checks.
• Conduct investigations and root cause analysis to resolve quality issues.
• Collaborate with the APAC Regulatory team on compliance and regulatory approvals.
• Support customer audits and monitor QMS aspects such as Change Control, CAPA, and Complaints.

Requirements

• Bachelor's degree in Science, Engineering, Bioengineering, or a related field (Chemistry or Biology preferred).
• At least 8 years of experience in Quality or Regulatory roles.
• Proven experience within the medical device, pharmaceutical, or biotechnology industry.
• Must be comfortable working in a cleanroom environment.
• Strong ability to develop, update, and train staff on SOPs.
• Proficiency in problem-solving techniques and root cause analysis.
• Experience monitoring QMS processes (CAPA, Change Control, Nonconforming Materials).
• Proficiency in Microsoft Office (Word, Excel, PowerPoint).

Preferred Qualifications

• Experience with SAP, EtQ, and/or PeopleSoft.
• Experience with statistical analysis and continuous improvement methodologies.
• Experience participating in new production line setups or product transfer projects.
• Experience in the setup of new cleanrooms.

About the Company

Corning is one of the world’s leading innovators in glass, ceramic, and materials science. Our Life Sciences segment provides innovative solutions that improve productivity and enable breakthrough discoveries for researchers worldwide, helping to ensure the delivery of lifesaving medicines.