QC Analyst Senior (m/w/d)

Tasks :

• Comply with cGMP, BPD, and EHS standards

• Perform routine and non-routine process activities.

• Provide coaching and share knowledge on routine and non-routine QC activities.

• Escalate technical and/or organizational issues.

• Propose technical or organizational solutions.

• Solve complex technical problems.

• Suggest and monitor continuous improvement ideas.

• Initiate work orders.

• Initiate or ensure the adequacy of deviation reports within the quality system (e.g., Trackwise) in a timely manner.

• Inform and raise awareness among production colleagues about deviations in their area.

• Ensure proper understanding and application of defined CAPAs in the QC area within the set timeframe.

• Present your area of expertise, deviations, and change control content during inspections.

• Have system, equipment, and method knowledge for your area of expertise.

• Manage OOX results and invalid data for your methods and related deviations in the system, acting as the subject matter expert; identify root causes and associated CAPAs.

• Participate in managing protocol deviations (review and SME support).

• Stay informed about new technologies and propose improvements.

• Train analysts on your specific methods, systems, and equipment.

• Support tracking of invalid data for your methods and help identify improvements, root causes, and CAPAs.

• Perform weekly control chart reviews for your methods.

• Conduct regular GEMBAs in the laboratory.

• Be responsible for critical reagents in your methods and ensure reagent availability for analyses.

• Act as a backup for other method and equipment owners.

• Actively participate in risk analyses for equipment and methods.

• Support periodic system reviews and ATR-RA.

• Be responsible for your method logbooks (completion, monthly review).

• Be able to identify and resolve certain complex problems related to your expertise.

• As a backup for the Equipment Lifecycle Owner, contact suppliers in case of technical issues with your equipment or method.

• Supervise suppliers during maintenance or unplanned interventions.

• In collaboration with QC Sciences, contribute to method improvement/harmonization between sites.

• In collaboration with QC Sciences, support regulatory submissions.

• Support projects as a subject matter expert (SME).

Qualification:

• Minimum education: CFC in laboratory/biology or another relevant scientific field.

• At least 5 years of QC laboratory experience in a cGMP environment.

• Experience in HPLC and LC-MS analysis. (must have)

• Fluent French and technical English.

• Swiss or EU nationality, or a valid Swiss work permit.

Requirements: