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Quality Assurance Specialist

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

Tucker, GA, US

Job Type:  Full Time
Job ID:  1189

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 The Netherlands 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 Assurance department ensures that raw materials, production processes, packaging, storage, transport and service continuously meet and exceed these high standards. This makes sure that our customers receive the consistent high Quality products from Corbion that they have become accustomed to.

 

The Quality Assurance Specialist is responsible for ensuring procedures, systems, and processes effectively meet the Quality requirements and business needs.

 

Responsibilities:

 

  • Support in maintaining and continuously improving the quality management system in compliance with GMP regulations and ISO requirements.
  • Manage Document Control processes (paper-based system + future EDMS with MasterControl) that control, review, approve, distribute, and administer GMP Documents, e.g., SOPs, Quality Manual, controlled forms, work instructions, logbooks, etc.
  • Support validation activities for migration of GMP Documents into EDMS.
  • Manage GMP training program (paper-based system + future LMS with MasterControl) 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 the QA department with Audits, CAPA’s, Change Control, Deviations, Root-Cause Analysis, and Complaint handling on QA procedures and the QMS.
  • Maintain current knowledge of FDA, EMA and other international regulations, guidance’s, and standards (such as ICH, USP, Ph. Eur.) applicable to industry. Monitor and identify developments to the legislations and translate these to the Biomaterials business.
  • Support internal and external customers’ Quality requests with timely follow up and participation in new business development projects.

 

 

Minimum Qualifications:

 

As a successful candidate you are a seasoned professional with experience in pharma, medical device, food or related FDA regulated industry. You have working knowledge of GMP regulations; ICH Q7; CFR 210/211; CFR 820/ISO 13485; ISO 9001:2015 and/or other applicable regulations.

 

In addition we expect the following qualifications:
 

  • Bachelor’s or Master's degree in Life Sciences, Engineering, or other relevant area.
  • Minimum 5 years of Quality Assurance experience in pharmaceutical, medical device or other related industries.
  • Experience in Document Control and GMP Training programs
  • Background in EDMS and LMS is a plus
  • Background in MasterControl is a plus.
  • 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.
  • 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 2019, Corbion generated annual sales of   € 976.4 million and had a workforce of 2,138 FTEs. 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 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

 

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.

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