At Corbion, we exist to champion preservation in all its forms, preserving food and food production, health, and our planet.
As our next Quality Assurance (QA) Associate, you will be responsible for supporting Quality Assurance activities to ensure that the site complies with cGMP standards, ISO 9001 certification, and Corbion requirements. You will also be responsible for maintaining the document control system, issuing batch records, and managing training records. Additional responsibilities include providing daily support for Manufacturing Operations, support for final product release, support for customer complaints, support for regulatory inspections, support for Supplier Quality, and support for releasing materials from incoming inspection.
Minimum Qualifications:
Bachelor’s degree in Life Science, Engineering, or other relevant area
2 years of quality experience in an FDA regulated environment
Experience working in Document Control and with GMP Training programs
Computer literate (Knowledge of Microsoft Office Word, Excel, Access, PowerPoint)
Excellent documentation and record-keeping skills
Knowledge of GMP regulations and quality standards
Ability to work independently and as part of a team
Exposure to supporting Manufacturing Operations
Knowledge of Deviation and CAPA creation and review/approval
Exposure to Regulatory Authority inspections (e.g. FDA, notified bodies, etc.)
Excellent written and verbal communication skills. Attention to detail, commitment to quality, accuracy, efficiency, and consistency
Preferred Qualifications:
4 years of Quality Assurance experience in pharmaceutical, medical device or other FDA regulated industry
Proven ability to work cross-functionally to achieve business outcomes
Previous knowledge of quality management systems and understanding of production processes
Experience working in SAP and MasterControl
ASQ Certification
Essential Job Functions:
Manage document control and the Document Management System (DMS) process in MasterControl, launch document packets, shepherd documents through the collaboration and approval process, maintain physical document storage and document retrieval, issue document numbers, etc.
Provide daily support for Manufacturing Operations, including logbook issuance/reviews, line clearances, batch records issuance, recipe issuance, etc.
Perform audit trail review for production systems in conjunction with Operations, support additional onsite data integrity activities.
Manage assignment of training courses to employees.
Provide assistance with the GMP training program which controls training records, support the development of training content and associated assessments, and coordinate instructional/hands-on exercises (OJT).
Assist with the preparation and revision of product specifications.
Assist with activities for Management Review and Quarterly Quality Review.
Support customer complaint investigations.
Support batch release process: in-process and final product release.
Assist with the review and approval of Quality Control data for raw materials, in-process testing, and final product testing including raw material release from incoming inspection.
Provide QA support for all deviations and CAPA investigations.
Assist with the site audit program (internal, customer, certification, regulatory inspections).
Support the Supplier Quality program Including maintaining Supplier Quality approval lists and conducting qualification activities with suppliers.
Continuously improve quality processes, procedures and documents.
Promote a safety mindset and focus on safety for all operations tasks/activities.
Physical Demands:
The work is performed mainly in an office environment and plant operations areas where PPE is required.
Through the course of a typical workday, an individual in this position will perform the following activities:
Sits (50-75%)
Stands (up to 25%)
Walks (25%)
Kneels (25%)
Bends (25%)
Reaches above and below the shoulders (25%)
Must be able to wear appropriate PPE; including safety glasses, safety shoes, and clean room gowning.
About Corbion
Corbion is the global market leader in lactic acid and its derivatives, and a leading supplier of emulsifiers, functional enzyme blends, minerals, vitamins, and algae ingredients. We use our unique expertise in fermentation and other processes to deliver sustainable solutions for the preservation of food and food production, health, and our planet. For over 100 years, we have been uncompromising in our commitment to safety, quality, innovation and performance. Drawing on our deep application and product knowledge, we work side-by-side with customers to make our cutting-edge technologies work for them. Our solutions help differentiate products in markets such as food, home & personal care, animal nutrition, pharmaceuticals, medical devices, and bioplastics. In 2024, Corbion generated annual sales of €1,288.1 million and had a workforce of 2,399 FTE. Corbion is listed on Euronext Amsterdam. For more information: www.corbion.com
Corbion is an equal opportunity employer and committed to a diverse workplace. All applicants will be considered equally without regard to race, color, ethnicity, veteran status, religion, national origin, marital status, political affiliation, age, sex, sexual orientation, handicapping condition, membership in an organization or any other non-merit factors.
Corbion provides reasonable accommodation to applicants.
EOE/M/F/Vet/Disabled
Corbion does not accept unsolicited resumes from individual recruiters or third party recruiting agencies in response to job postings. No fee will be paid to third parties who submit unsolicited candidates directly to our hiring managers. All candidates must be submitted by approved Corbion vendors who have been expressly requested to make a submission by our Talent Acquisition team for a specific job opening. No placement fees will be paid to any firm unless such a request has been made by the Corbion Talent Acquisition team and such candidate was submitted to the Corbion Talent Acquisition Team.
