About this role
Job title: Quality Specialist
About the Role Quality Specialist will develop and support all Quality Assurance activities and functions for the Singapore site, ensuring compliance with GMP, 21 CFR 820, ISO 9001 and Quality System Procedures. You will work with the Quality Manager to update SOPs, conduct SOP training, and manage documentation of the Quality System.
What You'll Do
- Direct and support 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 calibration program and record keeping
- Coordinate and lead Quality Documentation, Nonconformance Reports, Inspection Activities, and Product Disposition
- Review and revise procedures, specifications and forms to maintain and improve the QMS
- Collaborate with APAC Regulatory team on compliance activities including regulatory approvals
- Perform routine cleanroom monitoring activities, including airborne particle monitoring and differential pressure checks
- Conduct investigations and analysis to resolve quality issues
- Collaborate with organizational teams to support quality system implementation
- Support customer audits and maintain quality standards by following policies and procedures
- Identify, record and investigate problems related to product, process and quality systems; evaluate processes for improvements and standardization; initiate action to prevent non-conformance; train on quality systems; track/trend aspects of the QMS
What We're Looking For
- Bachelor’s degree in science, engineering, bioengineering or related field; Chemistry or Biology preferred
- At least 8 years’ experience in Quality or Regulatory in a medical device, pharmaceutical or biotechnology environment
- Travel < 10%
- Required skills: comfortable working in a clean room; ability to develop, update and train on SOPs; strong problem-solving and root cause analysis; ability to monitor the QMS (Change Control, CAPA, etc.)
- Good collaboration and communication skills; ability to work with APAC/regulatory teams
Nice to Have
- Experience with regulatory approvals; APAC regulatory collaboration; experience in life sciences QA environments