R&D Assay Documentation Specialist
Core
Generate design documents, reports, SOPs, and other documentation for the development of diagnostic assays (IVD) to support regulatory submissions.
Role type
R&D Assay Documentation Specialist
Builds
Design documents, reports, SOPs, batch records, and work instructions for diagnostic assays
Domain
Healthcare / In Vitro Diagnostics (IVD) / Molecular Biology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality and regulatory documentation, validation protocol preparation, SOP drafting, batch record tracking, filing system management, documentation review for compliance, version control, audit preparation
Preferred skills
Lab setting experience in life sciences, molecular biology techniques, QMS systems familiarity, ISO 13485 and FDA QSMR familiarity
Responsibilities
Support validation protocol, report, and technical document preparation, compilation, editing, maintenance, and filing; Draft and edit quality system compliant documentation such as SOPs, batch records, and work instructions for lab-related processes; Track batch records and checklists produced during IVD clinical validations and ensure compliance; Maintain appropriate filing systems; Documentation review for consistency and compliance; Help oversee implementation of new documentation and version control; Serve as a point of contact for documentation retrieval; Aid in preparation for internal and external audits; Manage multiple sources of information for documentation purposes; Help to continuously improve IVD and LDT development documentation and processes
Seniority
Mid-level, hands-on IC