Technical Writer- Assay Development

Job Description

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.
  

• 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

[email protected]/[email protected]