Specialist, Technical Documentation And Data Analysis

Location: Broomfield

Job Title:

Specialist, Technical Documentation and Data Analysis

Job Description

The Technical Documentation and Data Analysis Specialist, plays a crucial role in supporting Research & Development and Regulatory Affairs by performing data analysis and authoring technical documentation for immunoassay in vitro diagnostic (IVD) products. This role involves contributing 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.

This position is ideal for an early-career professional with hands-on experience in regulated environments looking to deepen expertise in assay data analysis and regulatory technical writing.

Responsibilities

+ 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.

Essential Skills

+ 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.

Additional

Skills & Qualifications

+ 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.

Work Environment

This role is based in an office environment with working hours from Monday to Friday, 8am to 5pm or 7am to 4pm. Occasionally, early morning calls at 7:30am 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.

Job Type & Location

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

Pay and Benefits

The pay range for this position is $33.17 - $37.98/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:  - 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)

Workplace Type

This is a fully onsite position in Broomfield,CO.

Final date to receive applications

This position is anticipated to close on Jun 4, 2026.

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