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About the role
The QC Analyst 3 (all genders) for IFF will independently and coordinatively contribute to the setup of laboratory activities, particularly in the qualification of equipment and the transfer of analytical methods in the In-Process Control (IPC) laboratory of the InsuLINK project at IFF. This includes the planning phase, qualification up to the final release of the laboratory, and the transition into routine operations. In collaboration with other quality functions, the job holder will support the development of procedures and documents as well as the commissioning of equipment and analytical methods in accordance with applicable GMP requirements, internal quality standards, and regulatory guidelines. The focus of the activity is on the independent practical execution of equipment commissioning and method transfer. Later, in routine operations, the focus will be on the independent execution and documentation of in-process testing, professional evaluation, and coordinating participation in analytical testing and quality assurance processes within the GMP-regulated environment of quality control.
The goal of the position is to sustainably ensure analytical quality, actively further develop processes, and provide professional support to colleagues.
We are looking for two QC Analysts (all genders). The positions will initially be worked on a flex-time basis. Further development towards a shift operation is possible in the future (and may become necessary depending on operational requirements.)
Main tasks:
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Active participation in and independent execution of equipment qualifications, analytical method transfers, and validation activities
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Active participation in the setup, qualification, and commissioning of an in-process control laboratory at IFF in compliance with all cGMP and HSE regulations as well as work instructions
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Independent execution of microbiological, chemical, and chemical-physical tests as part of in-process controls in the insulin manufacturing process
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Active support in troubleshooting and investigating analytical issues
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Conscientious documentation of all measurement results, raw data, and calculations in accordance with cGMP requirements
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Participation in the creation and review of laboratory protocols and reports
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Support in maintaining work instructions for analytical methods
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Calibration and maintenance of assigned equipment or coordination thereof, e.g., by external service providers, including associated documentation
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Recording of all expected raw data, calculations, and information related to his/her tasks to meet cGMP and data integrity requirements
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Participation in training and education; professional support and training of employees, apprentices, and working students
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Receipt, storage, documentation, handling, and disposal of reagents and reference standards
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Maintenance of documents, e.g., forms, test instructions, SOPs, SOP attachments, logbooks
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Immediate reporting of deviations, OOx results, or safety-relevant events to the supervisor
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Proper documentation of deviations and participation in corrective actions
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Contribution to the continuous improvement of laboratory processes
About you
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Education and professional experience Completed vocational training in chemistry, physics, biology, or pharmacy; further qualification (e.g., state-certified technician) is desirable; relevant professional experience in a quality control laboratory; strong professional experience in the field of instrumental analysis (HPLC, GC, UV, titration) as well as microbiological analysis (microscopy, contamination testing) is desirable; experience in in-process control analysis of active ingredients is an advantage
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Social competencies / Technical skills Strong experience in GMP-regulated work areas of quality control; cGMP knowledge; precise, independent, and structured way of working; ability to analyze complex data and laboratory results to make sound decisions and identify areas for improvement
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Languages Fluent German and English skills, both written and spoken
Pursue progress, discover extraordinary
Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
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The salary range for this position is :€0,00 - €0
Final compensation will be determined based on demonstrated experience, skills, location, and other relevant factors. Employees may be eligible to participate in Company employee benefit programs.