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Documentation & Data Specialist in Broomfield CO
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)
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 – 79K 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! #P1
10214210
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Why Kelly® Science & Clinical?
Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world’s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.About Kelly
Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.