Senior QA Specialist, Contamination Prevention & Control EM 80-100% (f/m/d)
Core
Deliver GMP-compliant environmental monitoring reports, trend evaluations, and contamination control assessments to support batch release and maintain state of control across the Visp site.
Role type
Senior QA Specialist (Environmental Monitoring & Contamination Prevention)
Builds
GMP-compliant EM reports, PQ monitoring reports, periodic trend evaluations, microbiological house-flora reports, and CCS status dashboards.
Domain
Life Sciences / Pharmaceutical Manufacturing / GMP Compliance
Deliverable
production ML models | product features | dashboards & analysis | client delivery | infrastructure | physical/clinical work
Required skills
Microbiology, GMP compliance, contamination control, data analysis, audit defense, complex investigation leadership, process improvement (lean/6S), GMP documentation authoring
Preferred skills
Data science tools (R, Python), Power BI, Power Automate, GMP systems (MODA, TrackWise, LIMS)
Technologies
R, Python, Power BI, Power Automate, MODA, TrackWise, LIMS
Responsibilities
Author GMP-compliant EM reports integrating microbiological expertise and site knowledge; Support review of EM outputs for batch release and certification; Combine cleanroom walkdown knowledge with data to identify trends and assess contamination status; Present and defend monitoring performance as SME in audits and inspections; Lead and support complex investigations across facilities using EM data; Contribute to cross-departmental CCS status dashboards; Identify and implement continuous improvement opportunities in reporting workflows
Seniority
Senior, hands-on IC
