Specialist, Technical Documentation And Data Analysis

Job Title: Specialist, Technical Documentation and Data Analysis

The Technical Documentation and Data Analysis Specialist supports Research & Development and Regulatory Affairs by performing data analysis and authoring technical documentation for immunoassay in vitro diagnostic (IVD) products. The role contributes to design control documentation and regulatory submissions under IVDR and FDA frameworks, ensuring technical content is accurate, traceable, and compliant with applicable quality system requirements.

• Draft, revise, and maintain technical documentation including protocols, validation and verification reports, stability reports, design inputs, and other design control deliverables.
• Ensure documentation is clear, consistent, and compliant with internal quality procedures and applicable IVDR and FDA requirements.
• Incorporate input from Subject Matter Experts (SMEs) to ensure scientific accuracy and regulatory appropriateness.
• Support preparation of documentation for regulatory submissions under guidance from Regulatory Affairs.
• Perform Excel-based analysis of assay performance data, including precision, accuracy, linearity, stability, and robustness studies.
• Prepare data tables, figures, and summary statistics for inclusion in technical reports and regulatory documentation.
• Review datasets for completeness and consistency and flag potential data issues to R&D and Quality partners.
• Work closely with R&D and validation team scientists, Regulatory Affairs, and Quality to support documentation and data needs.
• Participate in cross‑functional discussions to understand assay development activities and documentation requirements.

• Proficiency in Microsoft Excel, including data organization, formulas, basic statistical calculations, and creation of tables and figures.
• Strong proficiency in Microsoft Word; working knowledge of PowerPoint and Adobe Acrobat.
• Experience contributing to or authoring regulated technical documentation.
• Strong attention to detail and data integrity.
• Clear and effective written and verbal communication.
• Strong organizational and time‑management skills.
• Ability to manage multiple tasks with defined timelines.
• Ability to work independently with routine guidance and review.
• Collaborative and professional approach to cross‑functional work.
• Adaptability in a fast‑paced R&D environment.

• Bachelor’s degree in biological sciences, chemistry, biochemistry, biomedical engineering, or a related scientific discipline.
• 2–4 years of relevant experience in biotechnology, pharmaceutical, or in vitro diagnostics, or technical/scientific writing in a regulated setting.
• Experience in assay development, validation, or stability testing support.
• Immunoassays experience is essential.
• IVD and cGMP experience is a plus.
• Candidates with grant writing experience are not qualified.

This role is based in an office environment with working hours from Monday to Friday, 8 am to 5 pm or 7 am to 4 pm. Occasionally, early‑morning calls at 7:30 am with teams in New Jersey and Germany are required, which can be taken from home before commuting to the office. Initially, the position requires five days per week in the office for training and team collaboration.

Upon demonstrating proficiency, there is an option to work from home two days per week, subject to supervisor approval and business needs.

This is a Contract to Hire position based out of Broomfield, CO.

The pay range for this position is $33.17 – $37.98 per hour.

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre‑tax and Roth post‑tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long‑term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

This position is anticipated to close on June 9, 2026.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age,…