Documentation & Data Specialist in Broomfield CO

Documentation & Data Specialist in Broomfield CO Apply Now Applied To save a job sign in or get started

Job ID:

10214210 Posted today Back Broomfield, CO, US Scientific Bachelors Degree Full Time, Direct Hire &69-79K Experienced (Non-Manager) On-site Healthcare Services First Shift (Day) Broomfield, CO, US &69-79K Experienced (Non-Manager) Full Time, Direct Hire Healthcare Services On-site Scientific Bachelors Degree First Shift (Day) Apply Now Applied Job details Kelly® Science & Clinical is currently recruiting candidates for a Direct Hire Technical Documentation and Data Analysis Specialist position at a clinical lab in Broomfield CO. The overall responsibilities of the role are to support the company's Research & Development and Regulatory Affairs activities by performing data analysis and authoring technical documentation for immunoassay in medical diagnostic products. This role contributes to design control documentation and regulatory submissions under FDA frameworks, ensuring that technical content is accurate, traceable, and compliant with applicable quality system requirements.

Pay Range:

$69 - 79

K DOE Schedule:

Monday - Friday 8 hour day shift

Technical Writing and Documentation 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 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.

Data Analysis and Reporting Responsibilities:

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.

Qualifications:

Bachelor's degree in Biology, Biochemistry, Biomedical Engineering, or related field 5-10 years of relevant experience Proficiency in MS Excel including data organization, formulas, basic statistical calculations, and creation of tables and figures Strong proficiency in MS Word Experience contributing to or authoring regulated technical documentation Strong attention to detail and data integrity Strong organizational and time management skills Ability to manage multiple tasks with defined timelines If you meet the above qualifications, please submit your resume for immediate consideration! #

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