Senior Specialist I - Quality Assurance Operations, On the Floor

Role responsibilities

The Senior Specialist I in Quality Assurance ensures compliant manufacturing execution and participates in deviations, CAPA, and change control investigations. They also oversee Cell Bank inventory and support QA-on-the-floor documentation review.

Requirements

Candidates must have a PhD in a STEM discipline with 7+ years of experience, or a Master's with 10+ years, or a Bachelor's with 15+ years, or an Associate's with 17+ years of experience. Strong knowledge of cGMP, FDA, EMA, ICH guidelines, and experience with TrackWise and ComplianceWire are required.

Key skills

cGMP, FDA, EMA, ICH Guidelines, Investigations, Deviations, CAPA, Risk Assessments, Data Analysis, Trend Interpretation, TrackWise, ComplianceWire

Keywords

Quality Assurance, cGMP, FDA, EMA, ICH Guidelines, Investigations, Deviations, CAPA, Risk Assessments, Data Analysis, Trend Interpretation, TrackWise, ComplianceWire, Biologics, Pharmaceutical Manufacturing, COVID-19, Cancer, Autoimmune Disorders, HIV, Diabetes, Alzheimer's