Technical Specialist Microbiology QC (Yacht Life Sciences)

Janssen Biologics BV
  • Leiden
  • Detachering
  • HBO, WO
  • 40 uur
Apurva Inglekar avatar
Apurva Inglekar recruitment consultant

Yacht Life Sciences has a vacancy for a Technical Specialist Microbiology QC to work within the Quality Control department Janssen Biologics in Leiden.

The Technical Specialist will actively handle the medium and high quality and compliance issues at the laboratory independently or with help of the lab QC technicians. You will work to maintain cGMP compliance and LEAN status of the team. Furthermore, you will act as a Subject Matter Expert (SME) during cGMP inspections and you are a SPOC (Single point of contact) for the lab during new product implementations, investigations, qualifications, etc. 

The key responsibilities of the Technical Specialist Microbiology QC:

  • Responsible for deviation management, acting as lead investigator for non-conformances and coordinator of appropriate corrective/preventive actions.
  • Creates, reviews and updates lab documentation and NPI supporting documents.
  • Provides technical support to the lab, input in services group and cooperates with local/global key stakeholders.
  • Acts as a technical system owner for (analytical) equipment.
  • Acting as Subject Matter Expert during audits and inspections.
  • Leads and drives continuous improvement projects.
  • Role model to safety, compliance, and reliability
  • Collaborates and actively contributes to a team environment both with internal team members and supervisors 

Functie-eisen

  • Bachelor’s degree (HLO) or higher education in Life Sciences, molecular biology or comparable
  • >3 years experience with microbiology techniques; Bioburden, Endotoxin, Sterility and Speciation testing
  • Experience with quality and compliance issues
  • GMP experience is a plus
  • Written and oral communication skills in English

Competenties

  • Pro-active, able to work independently as well as in a team, flexible, structured
  • Analytical thinking and (technical) problem solving

Arbeidsvoorwaarden

This concerns a secondment contract with Yacht to work at Janssen Biologics (J&J) for 1 year, extension is anticipated. Full-time (40h) is strongly preferred, working 32 or 36 hours per week can be discussed. We will offer a competitive benefit package in line with the seniority of the position (salary between 3200 and 4200 euro gross per 4 week period). 

Bedrijfsinformatie

Janssen Biologics B.V. is one of the Janssen Pharmaceutical Companies of Johnson & Johnson, and is passionate about the development, production and marketing of vaccines and antibodies to prevent and combat infectious diseases. At the Leiden Site, hard-working and multi-scaled people are working in a high-performance culture in which innovation and a 'can do' state of mind are the central points.

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. 
 

Solliciteren

Inclusiviteit en diversiteit

Uiteraard staat deze vacature open voor iedereen die zich hierin herkent. We geloven dat diverse teams van belang zijn voor ons als lerende organisatie, die voorop wil blijven lopen in de wereld van werk. Want juist verschillen tussen mensen zorgen voor groei. Van collega's, klanten, kandidaten en daarmee van Yacht. Heb jij een uniek talent? We ontmoeten je graag.

Apurva Inglekar avatar
Apurva Inglekar recruitment consultant

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recruiter Apurva Inglekar

Apurva Inglekar

recruitment consultant

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