R&D Documentation Specialist

Job Summary

To support IVD projects, the full-time R&D Documentation Specialist will generate design documents, reports, and SOPs, while collaborating with cross-functional teams in a remote environment.

Key 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
• Manage multiple sources of information for documentation purposes and aid in preparation for internal and external audits

Required qualifications

• Bachelor's degree plus 2+ years of documentation experience in the medical device industry
• Organized and detail-oriented with excellent written and verbal skills
• Ability to work well with cross-functional teams
• Experience in a lab setting in life sciences and a thorough understanding of molecular biology and associated techniques is highly desirable
• Familiarity with ISO 13485 and FDA QSMR