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Quality Control Specialist Biomaterials

Job Category:  Quality
Work Location:  Corbion Site
Office Location: 

Gorinchem, NL

Job Type:  Full Time
Job ID:  843

Corbion develops sustainable solutions to improve the quality of life for people today and for future generations.

 

The 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 pills). The products are developed and produced (often to customer specifications) in our factories in Gorinchem and the United States. This requires very intensive contact with the customer. The application area and the specific market require a very high level of quality and service.

The Corbion Biomaterials Quality Control department ensures that these monomers and polymers produced meet these high standards. This makes sure that our customers receive the consistent high quality product from Corbion that they have become accustomed to.

 

The Quality Control Specialist Analytics is responsible for the purchase of new equipment, developing and validating analytical methods for existing and new products and implementation of data integrity requirements according to 21 CFR part 11.

 

Responsibilities

 

  • Implementing data integrity requirements according to 21 CFR part 11 by establishing Initial Risk Assessments, User Requirement Specifications and Validation plans for new equipment.
  • Developing and validating analytical methods according to ICH Q7 guidelines.
  • Establishing (Master) Validation documents.
  • Training of QC representatives on the equipment and methods.
  • Assisting in root cause investigations concerning deviations.
  • Assisting QC representatives with complex troubleshooting.
  • Supporting in customer requests.
  • Supporting in projects (New business development and Analytical Service departments).

 

Requirements

 

  • HBO/MBO education level.
  • Minimum of 3 years of work experience concerning method development and validation in a GMP environment.
  • Experience in implementation of data integrity requirements according to 21 CFR part 11.
  • Experience in computerized systems, proficient in Word and Excel.
  • Good written and verbal communication skills, in English and Dutch.
  • Attention for 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, lactic acid derivatives, and a leading company in emulsifiers, functional enzyme blends, minerals, vitamins and algae ingredients. Our sustainable ingredient solutions help differentiate products in markets such as food, home & personal care, animal nutrition, pharmaceuticals, medical devices, and bioplastics. With a worldwide network of production facilities, sales offices and agents in more than 100 countries, Corbion is known for quality, product innovation, and customer orientation, as well as for its collegial, informal and results-oriented company culture.

 

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.


Job Segment: Medical, QC, Pharmaceutical, Nutrition, Quality, Healthcare, Science

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