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QC Analyst Senior (M/F/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:
Start: asap
Duration: 6 months
Capacity: 5 days per week
Location: Neuchatel, Switzerland