Corbion US

Corbion is the global market leader in lactic acid and lactic acid derivatives, and a leading company in emulsifiers, functional enzyme blends, minerals and vitamins. We develop sustainable solutions to improve the quality of life for people today and generations to come. For over 100 years, we have been uncompromising in our commitment to safety, quality 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, pharmaceuticals, medical devices and bioplastics. We have factories in the Netherlands, Spain, Brazil, Thailand and the United States and a worldwide network of sales offices and agents in more than 100 countries. You can find more information about Corbion at www.corbion.com

Quality Assurance Specialist

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. We develop sustainable ingredient solutions to improve the quality of life for people today, and for future generations. 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. We have factories in the Netherlands, Spain, Brazil, Thailand and the United States. Corbion has a worldwide network of sales offices and agents in more than 100 countries. Quality, product innovation, and customer orientation are important attributes for our client, which is also characterized by being a collegial, informal and result-oriented company culture.

Position Summary:

The Quality Assurance Specialist is responsible for, but not limited to, ensuring procedures, systems, and processes effectively meet the Quality requirements and business needs. The successful candidate will be a seasoned professional with experience in pharmaceutical, medical device or related FDA regulated industry. The individual should have a thorough working knowledge of ISO 9001; ISO 13485; CFR 210/211; CFR 820 and other applicable regulations.

Responsibilities:

  • Responsible for site internal audit program.
  • Responsible for supporting deviation close out, writing investigation reports, and initiating follow up on corrective, and preventative actions.
  • Responsible for supporting quality related customer complaint investigations, and trending activities.
  • Assist in promoting continuous improvement of the Quality Management System.
  • Provide direct support during customer and regulatory audits.
  • Conduct self-inspections, and external audits as appropriate.
  • Support the review of all batch related documentation.
  • Support and maintain Environmental Health and Safety requirements, as applicable to the QA Department.
  • Provide advice, and knowledge with regard to interpreting Good Manufacturing Practice guidelines, and regulations.
  • Review and approve raw material, and finished product specifications.
  • Manage review of batch records, and associated documentation for release of finished product(s).
  • Ensure that all necessary documentation for release of product is completed, all deviations are resolved, and all specifications have been met, prior to release of any product.
  • Review, and manage environmental monitoring data in GMP clean room zones.
  • Provide training on the documentation/change control system, and associated policies and procedures as well as other elements of the quality system.
  • Assist in maintaining the vendor qualification program through timely audits and follow-up actions.
  • Develop, write and execute validation protocols (IQ/OQ/PQ, etc.), for equipment, systems, products and processes, write master validation plan and final validation reports.
  • Assist in establishing user requirement specifications (URS), and manage them in the quality system.

 Minimum Qualifications:

  • Bachelor’s degree in life sciences, or other relevant area
  • 5+ years of quality experience in pharmaceutical, medical device, or other related industries.
  • Working knowledge of FDA CFR 210/211, ICH Q7, ISO 9001 Certification, cGMPs as well as cGLPs
  • Strong written and verbal communication skills
  • Some exposure to regulatory agency inspections (e.g. FDA, notified bodies, etc.)
  • Proven ability to work cross-functionally to achieve business outcomes
  • Detail oriented, committed to accuracy, efficiency, and consistency
  • Must be proficient in Word, Excel and PowerPoint
  • Relevant ASQ certifications (auditing or quality management) are a plus
  • QC experience is a plus
  • Ability to travel – 10-20% as determined by business requirements including travel outside of U.S.

How to Apply:

The method for applying for this vacancy is online via the Corbion careers page at www.corbion.com. No other forms of application will be accepted.

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 with disabilities. If you need a reasonable accommodation for any part of the application and hiring process, please notify the Corbion Human Resources department. The decision on granting reasonable accommodation will be on a case-by-case basis.

EOE/M/F/Vet/Disabled

 


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