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Documentation Specialist

$33.82 per hour

TSR Consulting Services

TSR Consulting is currently seeking a highly motivated Electronic Documentation Specialist for an opportunity in Devens, MA! Job Title: Electronic Documentations Specialist Duration: 12 months Contract Pay Range: $33.82/hr (W2) Work Schedule: Mon - Fri, Business Hours Job Description Job Summary We are seeking an Electronic Documentation Specialist with experience supporting electronic document control systems in a GxP/GMP regulated environment . This role is responsible for managing controlled documents throughout their lifecycle, ensuring compliance with document governance standards, and supporting document routing, review, approval, formatting, and publishing activities within Veeva or similar electronic document management systems. The ideal candidate has strong Microsoft Word expertise , excellent document editing and formatting skills, and experience working with controlled procedures in a regulated pharmaceutical or biotechnology environment. Key Responsibilities Serve as a Document Control Specialist/Liaison for documentation managed within Veeva Document Control or a similar electronic document management system (EDMS). Edit, format, and maintain SOPs, work instructions, templates, procedures, and controlled documents. Route documents through electronic workflows for review, approval, and publication. Upload, track, and maintain documentation throughout its lifecycle within the electronic document management system. Ensure documentation complies with GxP/GMP documentation standards, internal procedures, and system requirements. Apply appropriate document types, version control, metadata, and document governance practices. Review documents for formatting consistency, grammar, punctuation, and overall quality. Collaborate with cross-functional teams to resolve documentation issues and ensure timely completion of document workflows. Manage multiple documentation requests while meeting established deadlines. Escalate documentation conflicts when necessary and recommend appropriate resolutions. Communicate effectively with internal stakeholders regarding document status and documentation requirements. Required Qualifications High School Diploma required; Associate's or Bachelor's degree preferred. (Master's degree candidates may be considered overqualified.) Experience supporting Document Control within a GxP/GMP regulated environment . Hands‑on experience with Veeva Document Control or similar electronic document management systems. Strong proficiency in Microsoft Word , including advanced document formatting and template management. Experience editing, formatting, routing, reviewing, approving, and uploading controlled documents. Excellent written communication, grammar, punctuation, and proofreading skills. Strong organizational skills with the ability to manage multiple priorities. Proficiency in Microsoft Office applications. Preferred Qualifications Experience supporting pharmaceutical or biotechnology documentation processes. Knowledge of document lifecycle management and electronic document governance. Experience working with cross‑functional teams in regulated environments. TSR Consulting offers all eligible employees a comprehensive benefits package including, but not limited to major medical, HSA, dental, vision, employer‑provided group life, voluntary life insurance, short‑term disability, long‑term disability, and 401k. #J-18808-Ljbffr

Vacancy posted 1 day ago
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