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Quality Analyst (M/F/D)
You have solid laboratory experience, including biochemical methods such as ELISA, PCR, enzyme activity assays, Western Blot, HPLC, or similar techniques.
Through your experience as a laboratory technician, you have developed a strong theoretical and practical understanding of biochemical methods and technologies.
Tasks:
Perform biochemical analysis and laboratory activities in accordance with applicable procedures, while complying with GMP/GDP requirements and/or supporting projects related to Quality Control activities.
Prepare solutions required for laboratory analyses.
Follow and apply all applicable procedures.
Comply with EHS (Environment, Health & Safety) requirements.
Complete various forms, logbooks, and documentation in accordance with Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and ALCOA+ principles.
Immediately inform the Supervisor, verbally and/or in writing, of any out-of-specification (OOS) and/or invalid results and initiate the corresponding quality event within the required timeframe.
Manage laboratory investigations.
Follow planning requirements and proactively escalate any issues or concerns.
Execute qualification protocols for reagents and consumables, as well as validation protocols for methods, systems, and equipment.
Ensure that equipment calibration and maintenance are up to date before performing analyses.
Manage Kanban processes in real time.
Escalate any procedural deviations or issues to the Method/Equipment Responsible Person and the Supervisor/Delegate/Expert.
Identify and resolve less complex issues within the relevant area of expertise through troubleshooting.
Prepare solutions and/or approve laboratory solutions, where applicable.
Maintain and organize the laboratory and comply with 5S standardization principles.
Support continuous improvement initiatives.
Qualification:
Minimum qualification: CFC Laboratory Technician, Biology, or another relevant scientific qualification.
Minimum 3 years of experience in a QC laboratory within a cGMP environment.
Experience with electrophoresis, HPLC, ELISA, or enzyme activity assays is preferred.
Fluent French and technical English.
Valid Swiss work permit.
Experience in writing method validation protocols is considered an advantage.
Requirements:
Start: asap
Duration: 9 months
Capacity: 5 days per week
Location: Neuchatel, Switzerland