Technical Writer - Assay Development

Dawar Consulting•Tucson, AZ

23d

About The Position

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

Requirements

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.

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.