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Technical Specialist Microbiology QC

Microbiology QC GMP bioburden endotoxin

Job

CLS Services is a leading professional recruitment agency specialised in chemistry & life sciences.
For our client Janssen Biologics B.V. we are searching for a Technical Specialist Microbiology QC.

Keywords
  • Microbiology
  • >3 years of experience
  • QC
  • Bioburden, endotoxin, sterility and specification testing
  • GMP

The Technical Specialist will actively handle the Medium and High quality and compliance issues at the lab independently or with help of the lab technicians. You will maintain cGMP compliance and LEAN status of the team. Additionally, you will act as Subject Matter Expert (SME) during cGMP inspections and you are SPOC (Single point of contact) for the lab during new product implementations, investigations, qualifications, etc.
Your responsibilities are:
  • Deviation management, act as lead investigator for non-conformances and co-ordinator of appropriate corrective/preventive actions;
  • Create, review and update lab documentation and NPI supporting documents;
  • Provide technical support to the lab, input in services group and co-operate with local/global key stake holders;
  • Act as a technical system owner for (analytical) equipment;
  • Act as Subject Matter Expert during audits and inspections;
  • Lead and drive continuous improvement projects.

Profile

The ideal candidate has the following requirements:
  • Bachelor’s degree (HLO) in Life Sciences, molecular biology or comparable;
  • 3-5 years of experience with microbiology techniques; Bioburden, Endotoxin, Sterility and Speciation testing;
  • Written and oral communication skills in English;
  • Pro-active, able to work independently as well as in a team, flexible, structured;
  • Analytical thinking and (technical) problem solving;
  • GMP experience is a plus.

Benefits

Salary: >38000
Days of leave: 36
See here our other employment terms for this vacancy
Project for at least 6 months

Company profile

Janssen Biologics creates, acquires and markets unique biopharmaceutical therapies. Their innovative products focus on the management of three major disease areas; cardiovascular, immunological disorders and cancer.

They strive to be a prominent company. Not only by the marketing of important new products. They also effectuate to increase the applications of their existing products. This means investing in the right research, forging the right business partnerships and hiring the right people to maintain the highest quality.

As a part of the QC Lab situated at the Janssen Biologics Manufacturing site in Leiden, the Microbiology test team is responsible for execution of test methods using various microbiological assays (e.g., Bioburden, Endotoxin, Sterility and Speciation testing), samples ranging from early clinical up to commercial process control, release, and stability. The Microbiology department consist of around 35 people.

Contact

Interested? Send us (CLS Services) a detailed curriculum vitae, accompanied by an application letter indicating your motivation. Please use our online application form.
Location Leiden
Technical Specialist Microbiology QC

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