QA Specialist

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) Specialist you will be responsible for performing QA activities to ensure that the site complies with cGMP standards ISO 9001 certification and Corbion requirements. You will also be responsible for finished product release investigating customer complaints regulatory inspection support supplier quality raw/packaging materials release and providing compliance guidance and daily support to Manufacturing Operations.

Minimum Qualifications:

• Bachelors degree in Life Sciences Engineering or other relevant area.
• 5 years of Quality Assurance experience in pharmaceutical medical device or other FDA regulated industries with a knowledge of GMP regulations.
• Prior experience supporting Manufacturing Operations.
• Proven experience in the creation review and approval of deviations and CAPAs.
• Hands on experience with document control systems and GMP Training programs.
• Exceptional written and verbal communication skills.
• Demonstrated experience with performing final product release for finished products.
• Experience with leading or performing customer supplier or internal audits.
• Exposure to Regulatory Authority inspections (e.g. FDA notified bodies etc.).
• Excellent attention to detail commitment to Quality accuracy efficiency and consistency.

Preferred Qualifications:

• 7 years of Quality Assurance experience in pharmaceutical medical device or other FDA regulated industries with a knowledge of GMP regulations.
• Advanced degree in Life Sciences engineering or other relevant area.
• Experience working in SAP and MasterControl
• Experience with GMP Regulations primarily ICH Q7. Knowledge of ISO 13485 and/or ISO 9001:2015 is a plus
• ASQ Certification

Essential Job Functions:

• Perform batch release process: in-process and final product release (batch record review); issue Certificate of Analysis.
• Provide daily support for Manufacturing Operations including logbook reviews line clearances batch records issuance recipe issuance etc.
• Investigate customer complaints.
• Review and approve quality control data for raw materials in-process testing and final product testing including raw material release from incoming inspection.
• Perform audit trail review for production systems in conjunction with Operations support additional onsite data integrity activities.
• Perform initial review and final approval for all deviations and CAPAs driving effective root-cause analysis to prevent recurrence.
• Support the audit program (internal customer certification regulatory inspections).
• Manage document control processes that control review approve distribute and administer GMP Documents
• Support the GMP training program that controls training records assigns GMP training curricula supports the development of Training content and associated assessments and coordinates instructional/hands-on exercises (OJT).

• Support activities for Management and Quarterly Quality Reviews.

• Support the supplier quality program by maintaining the 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.
• Other duties as determined by business needs.

Physical Demands:

The work is performed mainly in the QA offices 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 (75%)
• Stands (up to 25%)
• Walks (25%)
• Kneels (10%)
• Bends (10%)
• Reaches above and below the shoulders (10%)
• Must be able to wear appropriate PPE; including safety glasses and safety shoes.

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 1288.1 million and had a workforce of 2399 FTE. Corbion is listed on Euronext Amsterdam. For more information:

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.