Technical Writer- Assay Development
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
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Create, edit, and maintain technical documentation and product labeling for assay development and diagnostic products.
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Collaborate closely with R&D, Product Development, Quality, and Regulatory Affairs teams to gather and verify technical information.
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Ensure all documentation complies with internal standards, FDA, ISO 13485, and 21 CFR Part 11 requirements.
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Support the preparation and control of SOPs, work instructions, product manuals, and labeling content.
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Attend project team meetings and provide updates to supervisors on documentation progress and timelines.
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Participate in document review, approval, and change control processes within an electronic documentation management system (eQMS).
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Maintain version control and ensure timely updates to technical and regulatory documentation.
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Coordinate with cross-functional teams to ensure consistency and accuracy across all technical content.
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Assist in audits and inspections by providing compliant documentation as required.
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Identify opportunities to improve document templates, style guides, and documentation processes.
Qualifications & Education
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3–5 years of experience in technical or scientific writing within biotech, pharma, or medical device industries.
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Strong knowledge of FDA, ISO 13485, and 21 CFR Part 11 documentation standards.
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Skilled in creating and managing SOPs, work instructions, and product labeling.
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Experience with electronic document control systems (e.g., MasterControl, Veeva, Documentum).
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Excellent written communication, organization, and attention to detail.
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Bachelor’s degree in Biology, Biochemistry, Biotechnology, Chemistry, or a related field.
If interested, please send us your updated resume at
hr@dawarconsulting.com/sanya@dawarconsulting.com