Documentation Specialist

• 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
• Review documentation 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
• Continuously improve IVD and LDT development documentation and processes
• Work closely with Technical and Development Scientists, technologists, Quality, and Regulatory professionals
• Support the molecular R&D group in drafting documentation for regulatory submissions

R&D Assay Documentation Specialist

• 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
• Review documentation 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
• Continuously improve IVD and LDT development documentation and processes
• Work closely with Technical and Development Scientists, technologists, Quality, and Regulatory professionals