Senior QC Lab Equipment and Quality Record Specialist

Senior QC Lab Equipment and Quality Record Specialist

Lonza

Basel, Switzerland

We are looking for an agile person to join our Bio-Analytics support team. Your main responsibility will be quality records (Deviations/Investigations) in the Bio-Analytics unit. You will also be responsible for Bio-Analytics equipment (e.g. cooling devices, plate readers, SPR systems), their qualification in collaboration with our lab systems department, as well as quality records related to these equipment. Further tasks will include contribution to the set-up of a new LIMS system and the maintenance of our document training system. All activities are performed according to Good Manufacturing Practice (GMP) standards.

What you’ll do:

• Participate in deviation/investigation/CAPA writing for the QC Bio-Analytics department
• Maintain the training records and assignments within our global training management system for the QC Bio-Analytics department
• Support the qualification/validation of analytical equipment in QC Bio-Analytics laboratories
• Review and approve qualification/validation related reports as required following cGxP
• Maintain equipment in QC Bio-Analytics laboratories in alignment with relevant SOPs
• Act as subject matter expert for dedicated laboratory equipment within audits and inspections
• Collaborate with cross functional teams and stakeholders

What we’re looking for:

• Degree in Biochemistry, Analytical Chemistry, Pharmaceutical Sciences, Engineering or similar field or on the job training as an Analytical Lab Technician
• Excellent understanding of GxP/quality and relevant regulatory requirements
• Experience in analytical equipment qualification/ownership
• Experience in Biacore/SPR systems is a plus
• Knowledge of quality management systems (e.g. TrackWise) and training management systems (e.g. Cornerstone) is a plus
• Good communication and inter-personal skills. Ability to work in a highly dynamic environment
• Good knowledge of English (written and spoken), German is a plus