Quality Specialist at Gentian AS

Gentian is an ambitious and fast-growing diagnostic manufacturer looking for a new raw material Quality Specialist.

The Quality Control department at Gentian is responsible for controlling the quality of all our in vitro diagnostic assays for the global clinical laboratory market, both human and veterinary.

We are looking for a Raw Material Quality Specialist who will take responsibility for further developing purification and characterization techniques for antigens, antibodies and other critical raw materials.

Work tasks:

·      Identify and implement new technology for purification and characterization of critical raw material in close collaboration with our R&D team

·      Establish incoming control procedures and specifications for new raw materials

·      Continuously improve existing purification and characterization techniques with focus on quality and cost control

·      Plan and execute stability testing of critical raw materials

·      Perform statistical data analyses and trending

·      Identify and qualify new suppliers of critical raw materials

·      Plan and execute Lean/Six Sigma projects

·      Plan and execute analytical method validation

·      Perform risk assessments

·      Establish user requirement specifications for new equipment

·      Establish procedures for use and maintenance of equipment

·      Follow up service agreements with suppliers

Preferred qualifications and skills:

·      PhD or Master’s degree in analytical chemistry, biotechnology, chemistry or similar

·      Minimum 3-5 years of experience with analytical method development or similar preferably from biotech or pharma industry within the field of protein chemistry, protein characterization or protein analysis.

·      Expertise in statistics and data trending

·      Knowledge within GMP (Good Manufacturing Practice) and Lean/Six Sigma is an advantage

·      Good English and Norwegian communication skills

Personal skills:

·      Accountable

·      Accurate

·      Analytic

·      Solution and quality focused

·      Flexible and positive

·      Independent/self-driven

We can offer:

For the right candidate we offer an exciting opportunity in an innovative and fast-growing global company. We offer great potential for personal and professional growth with good conditions.

CV and application can be submitted either in English or Norwegian.