Quality Control Technician III

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

 

We develop 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.

 

As our next QC Technician III, you will perform and interpret analysis on all plant raw materials and finished products. You will maintain laboratory records, generate weekly reports to management regarding all approved batches, and interact with other department personnel and Production Supervisor and Managers.

 

 

Responsibilities: 

Following prescribed guidelines and under general supervision, the QC Technician III performs the following duties:

 

• Analyze all incoming raw materials and all finished products to ensure conformance to specifications. Approve or reject raw material or product based on analytical data.
• Maintain all applicable laboratory records regarding batch approval or rejection, raw material approval or rejection, and communicates this data to management personnel as required.
• Perform instrumental analysis using  IV (Inherent Viscosity), Residual Monomer, Gel Permeation Chromatography (GPC), FTIR, Water Content (Karl Fisher), Residual Solvent Testing, Atomic Absorption, DSC (Differential Scanning Colorimeter),NMR (Nuclear Magnetic Resonance), Foreign Particles, Heavy Metals, Gas Chromatography, Free Acid, and Acid Number.  
• Ensure equipment and instrument preventive maintenance, calibrations, and standards evaluation activities are conducted successfully per prescribed frequencies.
• Assist management team by performing internal audits (which includes inspections of plant, product or paperwork such as work instructions), EHS audits, and customer audits to ensure compliance to regulatory requirements.
• Ensure that all documentation is completed correctly. Enters and retrieves information from various computer based sources.
• Assist the Quality Control Manager on product investigations to assist in the resolution of product quality or complaint issues and effectively communicate findings to the management team.
• Effectively communicate with other department personnel and management
• Ensure  cleanliness of equipment before certain products are produced.
• Perform environmental samples as needed.

 

 

Qualifications:

 

• College degree required.  Degree in Chemistry, Biology or other relevant course of study.   
• Minimum 2 years' experience in a GMP regulated laboratory environment.   
• Exceptional computer and analytical skills. 
• Demonstrated experience in reviewing documentation in cGMP environment.     

 

General Working Environment:

• In the laboratory, analysis involving the use of strong acids, bases, and corrosive materials. Some chemicals have been listed as potential health hazards necessitating the use of fume hoods, protective clothing and other devices. Hot plates and ovens which operate at elevated temperatures are also used. Some flammable liquids are present. Hot liquid samples of products will be present in the laboratory on a regular basis. A microwave drying oven is also used for testing of hydrated products. Inspections of the plant or audits of paperwork may take individuals out of the laboratory and into the plant or outside the building in inclement weather.
• Personnel shall perform their duties consistent with cGMP, FDA and OSHA regulations.

 

Usual Physical Activities:

Through the course of a typical shift, an individual in this position will perform the following activities:

• Sits,
• Stands,
• Walks,
• Kneels,
• Bends,
• Reaches above and below the shoulders,
• Corrected vision, speaking ability, and hearing are usually involved in performing written and verbal job functions.
• Must be able to wear appropriate PPE.

 

 

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