Specialist konotrole kakovosti / QC Specialist
Core
Ensuring regulatory compliance and quality of processes and products in the microbiological and analytical domain.
Role type
QC Specialist (Microbiology/Analytics)
Builds
Production and analytical documentation, test results, and quality reports for pharmaceutical products.
Domain
Life Sciences / Pharmaceutical Manufacturing
Required skills
Microbiological testing, Analytical method validation, Root cause analysis, SOP creation, Data integrity, Equipment calibration, Trend analysis, Supplier qualification support, Sampling planning, Laboratory animal welfare compliance
Preferred skills
Experience in quality, development, or manufacturing, Knowledge of GxP regulations
Technologies
Microsoft Office
Responsibilities
Resolve OOX/microbiological deviations and complaints, Define corrective and preventive actions, Monitor and analyze quality KPIs, Review and approve analytical data/tests, Perform microbiological testing of materials and equipment, Support qualification and validation of locations, Ensure calibration of lab equipment, Support supplier qualification, Interpret microbiological results and report trends, Create and revise SOPs and analytical documentation, Prepare analytical data and reports (APQR, stability), Ensure proper archiving of documentation, Support lab associates in daily tasks and troubleshooting, Ensure knowledge sharing and training of new hires, Participate in global laboratory initiatives
Seniority
Entry to Mid-level, Hands-on IC
