Work Schedule
Other

Environmental Conditions
Office

Job Description

Location/Division Specific Information

Thermo Fisher Scientific in Lelystad is the Center of Excellence producing Animal Health ELISA diagnostic Products with ISO 9001:2015, GMP and USDA certification.

Discover Impactful Work:

This position performs quality control testing of raw materials, intermediate products and finished goods according to set procedures with due regard to product availability and integrity. The main purpose is to support the Quality Control team to sustain the quality of the kits produced. Operate within ISO 9001:2015 quality requirements. This position impacts the ability to meet production schedules. Decisions taken affect quality and integrity of products

• Performs QC tasks on produced components (In-process-control) and assembled kits (Final QC).
• Analyses QC results with the Supervisor Manufacturing Biologicals and QC.
• Performs stability testing to maintain shelf-life data and secures retained samples and kits.
• Performs Material Entrance Controls (stock samples, free samples, raw materials).
• Secures stock keeping reference samples (QC panels)
• Secures continuous availability of work stock QC panels.
• Coordinates accurate QC data for batch dossiers and trend analysis.
• Participates in projects.
• Write and maintain SOP's
• First line quality support for the manufacturing team.
• First line of support for manufacturing problems.
• Support process improvements of current manufacturing processes.
• Effective use of reference samples and biologicals.
• Deal directly with the Manufacturing and/or Manufacturing Biologicals team in the event of quality issue.
• Authority to reject raw materials, intermediate products and finished goods.

• Molecular Biology, Biochemistry qualification to BSc or equivalent, industrial experience in a related field is acceptable

• Preferred experience with ELISA techniques.
• Routine use of MS Project, MS Excel, MS PowerPoint and MS Word is essential.
• Experience within Quality Control.
• The job holder must have a technical background in GMP with a BSc in a relevant scientific field.

• The incumbent must be a good communicator who embraces a logical approach and is able to interact optimally with various teams to ensure coherent teamwork.
• Ability to follow written and verbal instructions, meet targets and complete vital paperwork.
• Good manual dexterity.
• Can work well in teams or individually.
• Ability to understand and interpret technical and business documents and apply appropriate actions.

• The Bio-diagnostic and Food Safety industry makes use of a wide range of technologies (including molecular biology, cell line generation, cell culturing and protein purification (DSP) technologies).
• All processes are characterized by strict safety and quality requirements, and pressure on timelines.
• Work should be performed in an efficient and effective manner to assure the sites overall competitiveness. In addition, due to the very high value of equipment, raw materials, intermediates and products, activities must be driven in a highly controlled manner.
• Due to the nature of the role, a fair amount of field, interpersonal skills, and flexibility in working hours are required.
• Balance the often-conflicting requirements from partners (customer, quality, cost, speed, people, inventory, and safety) to secure the desired outcomes in terms of cost and quality.
• Deal with significant activity peaks and conflicting timelines to ensure on time delivery of production.
• Continually challenge how products and processes can be improved in the spirit of continuous improvement and efficiency and cost gains.