Senior Specialist, On-the-Floor, Quality Assurance
Core
Provide real-time Quality Assurance oversight across internal manufacturing and Quality Control operations supporting cGMP mRNA drug substance production.
Role type
Senior Specialist, On-the-Floor Quality Assurance
Builds
Compliant, efficient, and high-quality mRNA drug substance production operations
Domain
Biopharmaceuticals / mRNA manufacturing / Quality Systems
Required skills
cGMP compliance, deviation management, CAPA, root cause analysis, risk assessment, data integrity, SOP authoring, GMP documentation, microbiology oversight, stability program management, audit support, mentorship
Preferred skills
AI-enabled quality solutions, digital transformation, contamination control strategies, method validation, external lab governance
Technologies
SAP, LIMS, MODA, eLN, CDS
Responsibilities
Perform routine walkthroughs of manufacturing suites and QC laboratories to verify facility conditions and GMP compliance; Make timely, risk-based quality decisions and escalate concerns to leadership; Partner with cross-functional teams to manage deviation events and OOS/OOT investigations; Author, review, and approve quality documentation including SOPs and batch records; Coach and mentor Manufacturing and QC personnel on GMP and data integrity; Support inspection readiness and audit preparation activities.
Seniority
Senior, hands-on IC