QC Associate

Description

• Responsible to independently execute, coordinate and review physico-chemical and biochemical assays under cGMP according to existing method SOPs (e.g. compendial testing/content/identity/purity for small molecules, biologics/large molecules)
• Responsible to document assay execution under cGMP following Good Documentation Practices (GDP) and flag relevant observations to the supervisor for further assessment
• Accountable for execution of operational tasks in the lab e.g. mobile phase preparations, calibration of equipment, adherence to and maintenance of 6S, consumable management and support of equipment maintenance.
• Support of validation and transfer activities in frame of new project introduction cGMP standards for audit readiness and supports onsite customer/regulatory audits
• Assists in investigation/troubleshooting for assigned tasks

Qualifications

• First hands-on experience in analytical methodologies like e.g. pH measurement, UV-Vis, turbidity (experience with HPLC, Elisa or similar technologies are a plus)
• Experience with GMP is a plus
• Apprenticeship or or equivalent in Analytical Chemistry, Biochemistry or related field
• Fluency in written and spoken English, German is an asset
• You enjoy routine analytical testing and look for a chance to set up and shape a brand new laboratory with us