Project Specialist Quality Control
Core
Project manage validation, qualification, and assay transfer activities for Quality Control testing within a biopharma environment.
Role type
Project Specialist, Quality Control Technical Resources
Builds
Validation and qualification activities, assay transfers to partner/contract sites
Domain
Biopharmaceuticals / Quality Control / Chemistry
Required skills
Project management, GMP environment experience, Assay transfer protocols, SOP development, Cross-functional communication, Discrepancy management, Method updates coordination
Preferred skills
Scientific improvement ideas, Independent project execution, Time management
Technologies
Microsoft Suite (Word, Excel, PowerPoint)
Responsibilities
Project manage validation and qualification activities within the QC TR Chemistry group, Write and revise assay transfer protocols to external partners and contract labs, Write and revise control test procedures and SOPs, Coordinate and participate in weekly project update meetings, Communicate to management any delay in validation/transfer timelines, Coordinate post-transfer investigations between contract sites and collaborative partners
Seniority
Mid-level, hands-on IC