Quality Control Associate in Microbiology
vor 2 Wochen
The ideal candidate has a background in microbiological analytical methodologies, works with cGMP-regulated computerized systems, and aims to establish a paperless lab. The role involves becoming a technical expert for classical and rapid methods, supporting the Microbiology Team, and participating in cross-functional activities.
Main Tasks
- Execute microbiology testing activities, including microbial identification, endotoxin testing (KCA and KTA) and detection of microorganisms (BacT/Alert).
- Support QC Microbiology operations by performing and reviewing routine Environmental Monitoring (EM), Utility Monitoring (UM), manufacturing support samples (e.g., cleaning), and in-process/drug substance samples.
- Work with cGMP-regulated computerized systems to ensure data integrity and support a paperless lab environment.
- Author and review GMP documentation, including protocols, procedures, deviations, and CAPAs.
- Develop technical expertise (SME) in classical and rapid microbiological methods and associated instrumentation.
Your Profile;
- Apprenticeship degree (Laborant EFZ) in Biology or related Life Science or Technical discipline.
- Experience within Biological Quality Control, Microbiology and analytical function.
- At least 1 year of experience of experience in pharmaceutical or biotech manufacturing environment.
- Analytical skills in Microbiology (Bioburden and endotoxin testing, Growth promotion test, etc…).
- A working understanding of modern analytical microbiological modalities to facilitate the execution of analytical quality strategies.
- Proficiencies with the Quality systems and business processes associated with Microbiology testing (drug substance).
- English fluent
- High level presentation and organizational skills.
- Strong technical skills and be proficient with typical productivity software (Word, Excel, Power Point, Visio, etc.).
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