Quality Analyst

K-Recruiting GmbH; Schweiz; Vor Ort; CHF 70.000 - 90.000; Vollzeit

Zusammenfassung

K-Recruiting GmbH is seeking a Quality Analyst (M/F/D) for a Neuchâtel, Switzerland assignment. You will perform biochemical analyses and QC activities in a cGMP environment, ensuring compliance with GMP/GDP and ALCOA+ documentation.

Start ASAP for 9 months, 5 days per week, on-site in Neuchâtel. Requirements include 3+ years in QC labs, experience with HPLC/ELISA/electrophoresis, fluent French and technical English, and a valid Swiss work permit.

Qualifikationen

• Minimum 3 years of QC laboratory experience in a cGMP environment.
• Experience with electrophoresis, HPLC, ELISA, or enzyme activity assays preferred.
• Fluent French and technical English.
• Valid Swiss work permit.
• Experience writing method validation protocols is an advantage.

Aufgaben

• Perform biochemical analysis and QC activities per procedures (GMP/GDP).
• Prepare solutions required for laboratory analyses.
• Follow and apply all applicable procedures.
• Comply with EHS requirements.
• Complete GMP/GDP/ALCOA+ documentation.
• Inform Supervisor of out-of-spec results and initiate quality events.
• Manage laboratory investigations."
• Follow planning requirements and escalate issues.
• Execute qualification protocols for reagents, consumables and validation protocols for methods, systems and equipment.
• Ensure equipment calibration and maintenance are up to date.
• Manage Kanban processes in real time.
• Escalate procedural deviations or issues to responsible persons.
• Identify and resolve simple issues within area of expertise.
• Prepare and approve laboratory solutions where applicable.
• Maintain 5S standardization in the lab.
• Support continuous improvement initiatives.

Kenntnisse

Biochemical methods

GMP/GDP compliance

Documentation skills

Quality control

Troubleshooting

Ausbildung

CFC Laboratory Technician, Biology or relevant

Tools

HPLC

ELISA

Electrophoresis

Jobbeschreibung

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 escalates 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