Quality Specialist

Corning is one of the world’s leading innovators in glass, ceramic, and materials science. From the depths of the ocean to the farthest reaches of space, our technologies push the boundaries of what’s possible.  ​

How do we do this? With our people. They break through limitations and expectations – not once in a career, but every day. They help move our company, and the world, forward. ​

​At Corning, there are endless possibilities for making an impact. You can help connect the unconnected, drive the future of automobiles, transform at-home entertainment, and ensure the delivery of lifesaving medicines. And so much more.​

​Come break through with us.

As a leading developer, manufacturer, and global supplier of scientific laboratory products for 100 years, Corning’s Life Sciences segment collaborates with researchers seeking new approaches to increase efficiencies, reduce costs and compress timelines in the drug discovery process. Using unique expertise in the fields of materials science, surface science, optics, biochemistry and biology, the segment provides innovative solutions that improve productivity and enable breakthrough discoveries.

Scope of Position:

This role will be part of the Corning Life Sciences team, supporting the upcoming Corning Dissolvable Microcarriers (DMC) production facility in Singapore. In this role, you will be working with the Quality Manager. You will develop and support all Quality Assurance activities and functions supporting the quality goals and quality metrics for Singapore site. You will be responsible for updating SOPs, conducting training on SOPs and general administration and documentation of the Quality System. We also look for you to assure compliance to in-house and/or external specifications and standards such as Good Manufacturing Practices, 21 CFR 820, ISO 9001 and Quality System Procedures.

Day to Day Responsibilities:

• Direct and support employee training, SOP creation and continual process improvement objectives
• Reviews batch records and perform product release activities
• Coordinates QC testing including sample submission and testing result review.
• Manage calibration program and record keeping
• Coordinates and leads Quality Documentation, Nonconformance Reports, Inspection Activities, and Product Disposition
• Coordinates the review and revision of procedures, specifications and forms to maintain and improve the QMS
• Collaborates with APAC Regulatory team to compliance activities including regulatory approvals
• Perform routine cleanroom monitoring activities, including airborne particle monitoring and differential pressure checks, to ensure compliance with environmental and operational requirements.
• Performs investigations and analysis activities to support resolution of quality issues
• Collaborates with organizational teams to support quality system implementation
• Support customer audit

Ensures quality standards by following company & departmental policies & procedures including, but not limited to:

• Product performance & quality verification. Identifying, recording and investigating problems related to product, process & quality systems.
• Evaluating processes for improvements and standardization. Initiating action to prevent non-conformance in products, process and quality systems.
• Training on quality systems as identified by supervisor and required by position.
• Tracking/trending aspects of the QMS.

Required Education: Minimum of bachelor’s degree in science, Engineering, Bioengineering or related field; prefer Chemistry or Biology degree programs

Preferred Years and Area of Experience: at least 8 years’ experience in Quality or Regulatory, preferably in a medical device, pharmaceutical or biotechnology environment/industry

Travel Requirements: Less than 10%.

Required Skills:

• Must be comfortable working in clean room
• Ability to develop, update and train on SOPs
• Problem solving techniques to perform investigations and drive root cause analysis
• Ability to monitor the QMS such as: Change Control, CAPA, Complaints, Nonconforming Materials and Products
• Batch record review and product release activities
• Knowledge of computer programs, such as Word, Excel, Powerpoint, etc.
• Adhere to strict safety guidelines and OSHA standards

Desired Experience / Qualifications / Skills:

• SAP, EtQ and/or PeopleSoft experience
• Experience with statistical analysis
• Familiar with quality tools, root cause analysis, and continuous improvement methodologies.
• Experience in participating in new production line setups or product transfer projects is preferred,
• Experience in the setting up of new cleanrooms is highly desirable.