Senior Associate Quality Assurance
Core
Oversee night or day shift operations for the commercial production of biological drug substance, ensuring product quality and market supply.
Role type
Senior Associate Quality Assurance (Biologics Manufacturing)
Builds
Biological drug substance for medical teams worldwide
Domain
Biotechnology / Pharmaceutical Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP pharmaceutical production knowledge, biological drug substance experience, batch record review, quality record support, pharmaceutical equipment operation and control, change control management, troubleshooting unit operations, investigation resolution and documentation, equipment log review, regulatory audit and inspection experience, problem solving with data assessment
Preferred skills
5+ years in commercial manufacturing environment, understanding of cGMP production, technical writing, verbal communication and presentation, cross-functional collaboration
Technologies
GMP systems, electronic batch record systems, equipment control systems
Responsibilities
Conduct quality assurance activities for solution/equipment preparation, cell culture, product purification, and drug substance filling; support electronic batch record review, change control, investigations, and product release; participate in new product introductions and equipment qualification; support continuous improvement initiatives
Seniority
Senior, hands-on IC