Overview
Scientist QC Bioanalytics (m/w/d) 80-100% at Lonza. Location: Visp, Switzerland. Relocation assistance is available for eligible candidates and their families, if needed.
What You’ll Do
* Responsible for the routine execution of biochemical methods, focusing on ELISA, qPCR, ProA and enzyme assays, while adhering to GMP and safety guidelines.
* Prepare qualification, calibration, and maintenance plans in line with GMP and regulatory requirements (IQ, OQ, PQ) according to guidelines and procedures. Verify proper installation of instruments (SpectraMax, qPCR, ViaCell, etc.) according to manufacturer specifications and GMP standards.
* Validate SMP Templates.
* Perform ERAS and DIRAS according to guidelines. Ensure all qualification data is accurate, complete, secure, and compliant with data integrity principles.
* Communicate with the responsible QUS, IT, QA and QC employees. Maintain awareness of software lifecycle management, including validation, updates, patches, and version control, ensuring continued compliance with GMP requirements.
* Demonstrate knowledge of electronic data capture, storage, backup, and retrieval processes to ensure compliance with data integrity principles (ALCOA+). Interpret system logs, error messages, and diagnostic tools to identify and resolve software or hardware issues during maintenance and qualification.
* Maintain ongoing GMP compliance through audits and continuous process improvements. Familiarity with regulatory guidelines relating to computerized systems in GMP environments (e.g., FDA 21 CFR Part 11 and EU Annex 11).
* Understand how instruments/robots interface with Laboratory Information Management Systems (LIMS) or other relevant platforms.
Key Requirements
* Bachelor or Master in science or equivalent.
* Experience with quality control laboratory instruments (e.g., SpectraMax, qPCR, ViaCell).
* Solid experience in the pharmaceutical industry in a GMP environment.
* Knowledge of analytical instrument qualification (AIQ) and computer system validation (CSV).
* Experience with software and IT programs.
* Structured, focused, and well-organized working attitude. Open-minded for new ideas, highly motivated and dynamic. Strong teamwork skills and flexibility for various tasks in a technology team.
* Good verbal and written communication in English.
Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability, protected veteran status, or any other characteristic protected by law.
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