Quality Assurance Specialist, On the floor (Overnights)
Core
Establish and support 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 facility operations and quality systems
Domain
Biopharmaceutical manufacturing
Required skills
SOP development, document review, on-the-floor quality review, audit support, quarantine management, continuous improvement, cross-functional collaboration
Preferred skills
Cleanroom gowning procedures, physical stamina for 10-hour shifts, lifting up to 50lbs
Technologies
Electronic document systems, batch record 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 quarantine and line clearances, mentor manufacturing staff, adjust schedule based on facility needs
Seniority
Mid-level IC (2-4+ years experience)
