QA Specialist II - Doc Control
Core
Manage, coordinate, and maintain cGMP documentation, procedures, and records to ensure controlled copies are reviewed, approved, issued, distributed, and archived within a biopharma quality management system.
Role type
Senior IC Quality Assurance Document Control Specialist
Builds
Controlled document and record systems for biopharma clients
Domain
Biopharma / Medical Device / Quality Assurance
Required skills
cGMP compliance, EU regulatory requirements, FDA 21 CFR Parts 210/211/820, eQMS configuration, document lifecycle management, SOP development, audit preparation, CAPA management, batch record reconciliation, continuous improvement
Preferred skills
Cross-functional project leadership, multi-site support, MS Office expertise, change control management
Responsibilities
Maintain Quality System Master Documents and lists; Facilitate workflows in electronic document management systems; Create and approve Client Batch Records; Issue and reconcile batch records and lab logs; Write and develop QA SOPs; Administer document filing systems; Lead Quality System Investigations and CAPA action items; Train others in doc control processes; Lead continuous improvement projects
Seniority
Senior, hands-on IC