Lead, Documentation Specialist

This position will be primarily responsible for drafting, editing, and standardizing GMP documentation for deviations, investigations, CAPAs, and change controls. Ensures records are clear, compliant, complete, and inspection-ready, aligning to site procedures, data integrity expectations, and applicable regulations. Partners with SMEs and cross-functional owners to translate technical content into high-quality QMS records with consistent structure and strong rationale.

Responsibilities

Draft and edit deviations and investigation narratives (event description, timeline, impact, conclusions).

Convert SME input into clear root cause documentation aligned to evidence.

Write CAPAs linked to root cause, including action plans and effectiveness checks.

Draft change controls (rationale, scope, impacted areas/docs, implementation plan).

Ensure records are complete, consistent, and inspection-ready (traceability, attachments, objective evidence).

Apply site procedures and data integrity / cGMP expectations in all Manufacturing QMS records.

Coordinate with cross-functional owners to improve first-pass approvals and ensure thorough investigations.

Support audits/inspections by quickly clarifying or revising QMS narratives as needed.