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Quality Control Analyst (M/F/D)
Tasks:
Perform QC analyses and sample collections in compliance with SOPs, cGMPs, and pharmacopoeial standards
Complete documentation (forms, logbooks, results systems) per Good Manufacturing and Documentation Practices
Notify supervisors of non-conforming/invalid results and initiate quality events within deadlines
Proactively report planning deviations and escalate procedural deviations as required
Comply with and promote EHS rules; address unsafe behaviors and open EHS events promptly
Participate in maintaining a safe, compliant lab environment during all activities
Execute validation and qualification protocols for methods, systems, equipment, and consumables
Perform recalculations, supervise external results, and reconcile controlled documents
Ensure equipment calibration/maintenance is current and report any issues.
Conduct GEMBAs, review alarms, and uphold 5S lab organization standards.
Train analysts and apprentices on equipment and GMP; act as a backup trainer
Maintain up-to-date training status (e.g., SABA) and complete modules on time.
Act as SME for methods/equipment, resolving complex issues and supporting CAPAs
Back up supervisor or QC lifecycle roles and contribute to risk analyses and regulatory submissions
Manage logbooks, trend reports, and data systems (RAM, Bolton) with strong data integrity focus
Assess result validity/conformity and escalate priority conflicts as needed.
Support and initiate corrective and preventive actions in collaboration with lab leadership
Qualification:
Minimum CFC (Swiss Federal Certificate) in microbiology or equivalent experience in the pharmaceutical or biotech industry.
2–5 years of experience in a cGMP lab or minimum 2 years as Analyst I.
At least 5 years of experience in a cGMP lab or minimum 5 years as Analyst II
Good to excellent knowledge of lab methods.
Good understanding of cGMP requirements.
Knowledge of Data Integrity and its application in a regulated environment.
Comfortable with standard office and IT tools (MS Office suite).
French and technical English required.
English level: minimum B2
Requirements:
Start: 21.07.2025
Duration: 4 months
Capacity: 5 days per week
Location: Neuchatel, Switzerland
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