Quality Assurance Specialist, On the floor (Overnights)
Core
Establish and maintain quality assurance programs for drug product facility start-up and operations, including formulation, filling, and packaging.
Role type
Quality Assurance Specialist (On-the-floor)
Builds
Drug product manufacturing facilities and processes
Domain
Biopharmaceutical manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
SOP development, batch record review, audit support, quarantine management, cleanroom gowning, physical stamina for 10-hour shifts, lifting up to 50lbs
Preferred skills
Cross-functional collaboration, continuous improvement initiatives, mentorship
Technologies
Electronic document systems, batch documentation systems
Responsibilities
Develop and approve SOPs and specifications, perform on-the-floor quality reviews of equipment logs and batch records, support audits and investigations, manage material quarantine and line clearances, adjust schedules based on manufacturing needs
Seniority
Mid-level IC (2-4+ years experience)