Specialist Quality Assurance (Technical Support)
Core
Provide quality oversight and leadership for quality systems execution and operations support in non-direct manufacturing areas (Facilities & Engineering, QC, Technology, Process Development, Validation) for Biologics and Synthetic Manufacturing plants.
Role type
Specialist Quality Assurance (Technical Support)
Builds
Quality systems execution and operations support for biologics and synthetic manufacturing plants
Domain
Pharmaceutical / Biologics manufacturing
Required skills
GMP compliance, quality management systems, deviation management, root cause analysis, regulatory inspection coordination, change control, CAPA management, validation oversight, NPI support, technical writing, problem solving
Preferred skills
Project management, bulk manufacturing of biopharmaceuticals/API experience, quality assurance in pharmaceutical/biologics industry, manufacturing or process development experience
Technologies
GMP, cGMP, Quality Management System, Validation, NPI
Responsibilities
Provide quality oversight to plant operations ensuring GMP compliance; Support routine GMP documentation review; Co-lead deployment of quality systems; Review and approve complex quality records and lead root cause investigations; Lead QA oversight in commissioning/qualification/NPI; Coach QA professionals; Participate in regulatory inspections; Lead continuous improvement projects
Seniority
Specialist (Mid-level)