Lead, Documentation Specialist

Role: Document specialist responsible for drafting, editing, and standardizing GMP records related to deviations, investigations, CAPAs, and change controls within a biopharma manufacturing environment. Objectives: ensure records are compliant, clear, and inspection-ready, supporting quality and regulatory audits. Responsibilities: create high-quality documentation translating technical input into traceable, evidence-supported narratives; collaborate cross-functionally to improve process approvals and investigations; uphold data integrity and cGMP standards. Requirements: BS/BA in chemistry, biology, or biochemistry; minimum 3 years GMP experience including 2+ years authoring change controls or deviation investigations; proficiency with controlled documentation, CAPA processes, and project management; strong attention to detail and communication skills; proficient in Microsoft Office. Preferred: over 5 years GMP experience with 3+ years in deviation/change control roles. High-value specifics: GMP manufacturing, cGMP compliance, deviation/investigation documentation, CAPA, change control, regulated environment. Work setup: not specified; focus on manufacturing quality documentation.