QC Scientist, Analytics & Validation

At Corbion, we exist to champion preservation in all its forms, preserving food and food production, health, and our planet.

Corbion develops sustainable solutions to improve the quality of life for people today and for future generations. Our Biomaterials Business Unit develops, produces and sells monomers and degradable polymers as raw materials for the medical and pharmaceutical industry. Our products are used, among other things, in the production of surgical aids and slow-release medicines (injection and tablets). The products are developed and produced (to customer specifications) in our manufacturing sites in The Netherlands and the United States. This requires very intensive contact with the customer.

Our Quality Control department ensures that the raw materials, monomers and degradable polymers meet all the required specifications by analyzing the products according to validated methods. This makes sure that our customers receive the consistent high quality product from Corbion that they have become accustomed to.

We are hiring our next QC Scientist Analytics and Validation. In this role, you will be responsible for ensuring data integrity and development and (re)validation of analytical methods in the QC department according to the current guidelines and requirements. 

Responsibilities:

• Execution of the Data Integrity Compliance Program with the focus on Computerized System Validation
• Development and/or (re)-validation of analytical methods according to ICH Q2 guidelines.
• Approve protocols, reports and records.
• Support QC department with IT related projects, updates etc.
• Coordinate the purchase and qualification of new equipment. Calibrate, monitor (with documentation), and troubleshoot instrumentation to ensure communication of accurate testing results to internal and external customers.
• Support QC department with Out of Specifications (OOS), Deviations, CAPA's, Change Control, and Root-Cause analysis.
• Train peers in the appropriate procedures and practices to ensure consistent and accurate testing results.
• Support the maintenance and continuous improvement of the Quality Management System in compliance with ISO 9001 / ICH Guidelines / G(A)MP.
• Other duties as determined by business needs.

Minimum Qualifications:

As a successful candidate, you are a seasoned professional with experience in pharmaceutical, medical device, or related FDA regulated industry. You have working knowledge of GMP regulations.

In addition we expect the following qualifications:
 

• Bachelor’s degree in Life Sciences, Engineering, or other relevant area.
• Minimum 5 plus years of experience in an FDA regulated environment.
• Experience in implementation of qualification and validation guidelines for computerized systems, such as GAMP5, 21 CFR Part 11, ICH validation, EudraLex Annex 11.
• Experience in the development and/or (re)-validation of analytical methods according to ICH guidelines.
• Strong computer, communication and analytical skills
• Proven ability to work cross-functionally to achieve business outcomes.
• Attention to detail, commitment to Quality, accuracy, efficiency, and consistency.

Our offer

We offer competitive remuneration and benefits. What makes Corbion special is the way we consciously create that connection between the product of our work and our individual lives and use it to shape our choices and our priorities as a company. We have a great company made up of talented, dedicated people – people who share a purpose and a vision. When we all understand how we intend to get there in the same way, there’s no telling how far we can go. We offer you the chance to join a company with a:

• Culture to empower people and where your initiatives and ideas make a real difference
• International focus with truly diverse teams
• Unique possibility to be trained by our internal expertise in the world of biobased products
• We invest in relevant training courses related to your particular discipline, that will give you the opportunity to grow into an industry expert
• Lastly, we offer a friendly, informal culture in a demanding professional environment

In addition, we actively embrace diversity in how we work together and contribute toward our shared objectives and values. By joining Corbion, you will become an employee in a company where you can feel pride in your achievements and develop your career with global prospects.

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 2022, Corbion generated annual sales of   € 1,457.9 million and has a workforce of over 2601 employees. 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.