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Technical Writer- Assay Development
Job in
Tucson, Pima County, Arizona, 85755, USA
Listed on 2026-03-03
Listing for:
Dawar Consulting, Inc.
Full Time
position Listed on 2026-03-03
Job specializations:
-
IT/Tech
Technical Writer, Data Analyst
Job Description & How to Apply Below
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., Master Control, Veeva, Documentum).
- Excellent written communication, organization, and attention to detail.
- Bachelor's degree in Biology, Biochemistry, Biotechnology, Chemistry, or a related field.
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