Technical Writer- Assay Development
22 days ago
Tucson
Job Description Our client, a world leader in diagnostics and life sciences, is looking for a "Technical Writer- Assay Development" based out of Tucson, AZ. Job Duration: Long Term Contract (Possibility Of Conversion & Extension) Pay Rate : $27/hr on W2 Company Benefits: Medical, Dental, Vision, Paid Sick leave, 401K Responsibilities * Create, edit, and maintain technical documentation and product labeling for assay development and diagnostic products. * Collaborate closely with R&D, Product Development, Quality, and Regulatory Affairs teams to gather and verify technical information. * Ensure all documentation complies with internal standards, FDA, ISO 13485, and 21 CFR Part 11 requirements. * Support the preparation and control of SOPs, work instructions, product manuals, and labeling content. * Attend project team meetings and provide updates to supervisors on documentation progress and timelines. * Participate in document review, approval, and change control processes within an electronic documentation management system (eQMS). * Maintain version control and ensure timely updates to technical and regulatory documentation. * Coordinate with cross-functional teams to ensure consistency and accuracy across all technical content. * Assist in audits and inspections by providing compliant documentation as required. * Identify opportunities to improve document templates, style guides, and documentation processes. Qualifications & Education * 3–5 years of experience in technical or scientific writing within biotech, pharma, or medical device industries. * Strong knowledge of FDA, ISO 13485, and 21 CFR Part 11 documentation standards. * Skilled in creating and managing SOPs, work instructions, and product labeling. * Experience with electronic document control systems (e.g., MasterControl, Veeva, Documentum). * Excellent written communication, organization, and attention to detail. * Bachelor’s degree in Biology, Biochemistry, Biotechnology, Chemistry, or a related field. If interested, please send us your updated resume at /