Documentation Specialist for IVD Projects - Remote

Overview

We are looking for a key contributor for IVD projects in the generation of design documents, reports, SOPs, and other documentation towards the development of diagnostic assays.

In Short

• Support validation protocol, report, and technical document preparation.
• Draft and edit quality system compliant documentation.
• Track batch records and ensure compliance.
• Maintain appropriate filing systems.
• Documentation review for consistency and compliance.
• Help oversee implementation of new documentation.
• 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.

Requirements

• Bachelor’s degree plus 2 years of documentation experience in the medical device industry.
• Organized and detail oriented.
• Excellent written and verbal skills.
• Ability to work well with cross-functional teams.
• Team driven.

Benefits

• Full range of benefits including incentive compensation and medical benefits.