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:
- Bachelor’s 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 €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.
