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

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

35 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.

Bachelors degree in Biology Biochemistry Biotechnology Chemistry or a related field.

If interested please send us your updated resume at

/ sanya @

Required Skills :

accounts receivable A / R discrepencies disputes corrections

Required Education : Bachelors

Key Skills

Proofreading,Adobe Acrobat,Content Management Systems,Technical Writing,Visio,Microsoft Powerpoint,Sharepoint,XML,Confluence,Wiki Systems,Word Processing,Writing Skills

Employment Type : Full Time

Experience : years

Vacancy : 1