Quality Control Microbiology TechnicianMichael Page

Our client is a global science and technology leader in the medical devices sector

Work in a microbiological Quality Control laboratory (BSL-2) as per established procedures and work instructions in compliance with good manufacturing/laboratory practices (GMP/GLP)* Perform Bioburden analysis on raw materials and semi-finished products using a rapid alternative method (Scan RDI)

* Perform Bacterial Endotoxins Test on finished products using a rapid alternative method (LAL analysis with Charles River cartridges)

* Perform Environmental Monitoring of ISO7 / ISO8 cleanrooms (viables and non-viables sampling)

* Interpret inspection results in comparison with established specification and edit quality control reports

* Perform test result investigations for root cause and reports findings in case of non-conformities

* Write / update the Procedures and Work Instruction according to the needs of the evolution of the laboratory

* Participate to analytical method validation or equipment qualification

* Support other department such as Production, Manufacturing or R&D in different development projects

* Maintains a safe and healthy work environment by following standards and procedures.

* Analyse, evaluate, and interpret KPI's data and propose optimization of operations to improve these KPI's.

* Perform additional duties as required in the Quality Control laboratories

* CFC with professional maturity or equivalent diploma (such as BTS, DUT …)

* Minimum of 3 years of experience in Quality Control / Microbiology laboratory in Medical Devices or GMP environment

* Good experience in Microbiology process, methods

* Understanding of norms: ISO 11737 (part 1 and 3), ISO 14644, ANSIAAMI ST72

* Understanding of pharmacopoeia: USP<61>, USP<85>, USP<161>, EP 2.6.12, EP 2.6.14

* Ease of use Microsoft Office

* Analytical spirit, responsible, precise, rigorous and team player

* French language, English is a plusTechnician will work :

- in a BioSafety Laboratory Class II (BSL-2)

- in ISO7 / ISO8 cleanrooms