Document QA Engineer
Core
Managing, scanning, maintaining, and archiving GMP documents and training records in a factory to ensure compliance with regulatory requirements.
Role type
Document QA Engineer
Builds
Compliant quality system documentation and training records for factory operations
Domain
Manufacturing / Quality Management / GMP Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP regulations knowledge, document control, record maintenance, Veeva system proficiency, TrackWise system proficiency, training record management, Microsoft Office proficiency
Preferred skills
Pharmacy or Chemistry background, audit support experience
Technologies
Veeva, TrackWise, Microsoft Office
Responsibilities
Modify formats of quality system documents (SOPs, TWIs, record forms), organize regular document reviews and updates, collect and archive GMP-related records, maintain and optimize Veeva and TrackWise systems, organize and update training plan documents, maintain training record databases and track employee training status
Seniority
Entry-level to Mid-level
