Corbion - Tucker, GA
posted 24 days ago
About the position
At Corbion, we exist to champion preservation in all its forms, preserving food and food production, health, and our planet. In the medical and pharmaceutical market, Corbion is the market leader in the production of resorbable polymers and high-strength, degradable biocomposites for the medical device and pharmaceutical industry. Our resorbable polymers and biocomposites are used to produce orthopedic implants, drug delivery systems, and wound closure applications. We are now hiring a Quality Engineer for our facility in Tucker, GA. As our next Quality Engineer, you will be responsible for maintaining the quality management system and for providing oversight to validation/qualification and operation of processes, facilities, equipment, and computer systems in order to comply with cGMP and Corbion requirements. You will also be responsible for supporting Quality Assurance by creating, reviewing and approving protocols, procedures, reports, and other GMP records necessary to provide quality oversight and support.
Responsibilities
- Provide Quality oversight for commissioning, qualification, and validation of equipment, processes, utilities, facilities, cleaning, and computerized systems to ensure work is performed in a compliant and controlled manner.
- Maintain current knowledge of US FDA, industry and applicable international regulatory and legislative requirements and trends to ensure that expert advice and appropriate technical support is provided to site functions.
- Support and ensure compliance of product and process transfers, including validation, from other manufacturing sites.
- Provide support for implementing and overseeing the QMS related to the overall GMP compliance of the facility.
- Assist in managing quality systems and processes, including change control (process owner), CAPA, deviations, investigations, laboratory controls, Quality Reports, and Management Review.
- Contribute to quality risk analysis.
- Support internal/external audits, certification audits, and regulatory inspections.
- Promote a quality mindset and quality excellence approach to all activities.
- Promote a safety mindset and focus on safety for all operations activities.
Requirements
- Bachelor's degree in Engineering, Chemistry, Biology, Microbiology, or a related field
- 5 years' experience in an FDA regulated environment
- Experience drafting, reviewing, and approving validation protocols
- Experience leading and/or executing risk assessment activities, such as FMEA, fault tree analysis, 5 Why's, Fishbone analysis, etc.
- Proficiency in data analysis and interpretation
- Excellent documentation and record-keeping skills
- Expert knowledge of GMP regulations and quality standards
- Ability to work independently and as part of a team
Nice-to-haves
- Advanced degree in chemistry, engineering, or other relevant area
- 7+ years' experience in an FDA regulated environment.
- ASQ Certified Quality Engineer (CQE)
