Sr QA Specialist
Core
Lead on-floor quality assurance activities for product and raw material disposition, ensuring compliance with QA policies, cGMPs, and SOPs in biologics manufacturing.
Role type
Senior IC Quality Assurance Specialist (Shop Floor)
Builds
Dispositioned product and raw materials
Domain
Biologics manufacturing / Pharmaceutical Quality Assurance
Required skills
Biologics manufacturing operations knowledge, deviation investigation, change control management, CAPA management, cleanroom gowning procedures, document review and approval, process evaluation, team supervision
Preferred skills
Attention to detail, ability to stand for extended periods, prioritization of multiple assignments
Technologies
cGMPs, SOPs, QA Standard Requirement Documents
Responsibilities
Represent QA in complex deviation, change control, and CAPA investigations; liaise with external partners on regulatory communication; train and mentor employees; provide on-floor QA guidance; review and approve product disposition activities; supervise direct reports
Seniority
Senior, hands-on IC