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 (Manufacturing & QC)
Builds
Compliant, efficient, and high-quality mRNA drug substance production operations
Domain
Biopharmaceuticals / mRNA manufacturing / Quality Systems
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP compliance, deviation management, CAPA implementation, root cause analysis, risk assessment (ICH Q9), data integrity (ALCOA+), SOP authoring/review, batch record review, environmental monitoring oversight, stability program oversight, GMP documentation practices, cross-functional collaboration, coaching/mentoring
Preferred skills
AI-enabled quality solutions, digital transformation initiatives, method lifecycle management, external laboratory governance, inspection readiness
Technologies
SAP, LIMS, MODA, eLN, CDS, electronic batch records
Responsibilities
Perform routine walkthroughs of manufacturing suites and QC laboratories to verify GMP compliance and aseptic behaviors; Make timely, risk-based quality decisions and escalate concerns to leadership; Partner with cross-functional teams to manage deviation events, OOS/OOT investigations, and non-conformances; Author, review, and approve quality documentation including SOPs, work instructions, and APQR inputs; Provide shift-based QA oversight and support QC operations including occasional QC support; Coach and mentor Manufacturing and QC personnel on GMP and data integrity expectations; Support inspection readiness and participate in health authority inspection activities.
Seniority
Senior, hands-on IC
