Adam Samet
North Brunswick,USA
Summary
Experienced technical writer specializing in crafting SOPs, work instructions, and regulatory-compliant documents in FDA-regulated environments. Facilitates collaboration among Regulatory, Quality, Manufacturing, and EHS teams, proficient in managing document change controls and compliance materials. Skilled at simplifying complex processes for clarity and accessibility. Seeking a medical writing role focused on clinical documentation and immunology.
Overview
2
2
years of professional experience
Work History
Technical Writer II
QuidelOrtho
03.2023 - Current
- Created and maintained SOPs, Batch Records, Work Instructions, and technical documents for manufacturing, laboratory operations, and quality assurance.
- Provided documentation guidance and structure to SMEs using best practices.
- Edited and standardized content across departments to meet company and regulatory standards.
- Led document revisions to address CAPAs and NCs, ensuring FDA compliance.
- Managed timelines and deliverables as project lead, collaborating with Regulatory, Manufacturing, Engineering, and EHS teams.
- Participated in multi-site/global documentation updates to maintain consistency across locations.
Education
Bachelor of Arts - English Writing
Kean University
Union, NJ01.2022
Associate of Science - Education
Middlesex County College
Edison, NJ01.2020
Skills
- Medical & Technical Writing
- Document Management Systems: Windchill, TrackWise
- Regulatory Compliance: FDA, CAPAs, NCs
- Instructional Content Development
- SOP & Batch Record Creation
- Project Management & Team Collaboration
- Editing & Standardization
- Tools: MS Word, Excel, PowerPoint, Visio
- Communication: Verbal & Written Excellence
- Adaptive Thinker
Accomplishments
Received Encore Award for the timely execution of revisions to 120+ manufacturing documents.
Received Employee of the Month (September 2024)for the aid in creating technical documentation of new work in progress materials.
Timeline
Technical Writer II
QuidelOrtho
03.2023 - Current
Associate of Science - Education
Middlesex County College
Bachelor of Arts - English Writing
Kean University
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