Documentation Specialist - 100% Remote

Spectraforce Technologies
United States, Illinois, Avon
Apr 28, 2025
Job Title: Documentation Specialist - 100% Remote Duration: 12 months Supporting multiple time zone, early morning meetings, late afternoon meetings potentially. Purpose: Describe the primary goals, objectives or functions or outputs of this position. Serves as the Subject Matter Expert for documentation support activities including: document formatting, and change request review and approval facilitation. Candidate will support five biologics manufacturing sites across North America and Singapore (locations include Illinois, Massachusetts, Puerto Rico, California, and Singapore). The role involves aligning procedures across all five sites and submitting them to the Document Control group. Responsible for change control documentation - reviewing, routing, tracking, submitting, and resolving any hold-ups in the process. Candidate will pull documentation and use the OneVault Enterprise Documentation System (used across the organization). What are the top 3-5 skills requirements should this person have? Strong technical understanding of general biologics manufacturing unit operations, aseptic processing skills, and the nomenclature utilized in biologics manufacturing (facility, utility and equipment) Must have a basic to intermediate understanding of biologics manufacturing and bioprocessing operations - including bioreactors, chromatography skids, ultrafiltration, and cleanroom facilities. Experience with GMP change control documentation and document lifecycle from draft to approval to effective status is essential. Familiarity with contamination risk in biologics and how it is mitigated is preferred. Strong administrative and documentation processing skills, including the ability to route, submit, track, and follow up on documentation within compliance frameworks. Advanced understanding of the 'One Vault' Quality Documentation Management System. Advanced understanding of documentation change control, documentation processing and administrative tasks with processing a document from draft status to Approved status to Effective status. Advanced understanding of biologics contamination risk, mediation of contamination risk and a background in biologics laboratory &/or manufacturing operations Technical degree in Chemistry or Biology or Chemical Engineering with 5-10 years of biologics manufacturing experience. Responsibilities: List up to 10 main responsibilities for the job. Include information about the accountability and scope. Facilitates the review and approval of new and revised documents. Maintains document notifications within the document management system. Ensures all administrative documentation requirements are met. Qualifications: List required and preferred qualifications (up to 10). Include education, skills and experience. Preferred Experience: Knowledge and hands-on experience with Document Management Systems. Experience in detail-intensive and customer-focused environments. Excellent organizational skills, attention to detail, and strong oral and written communications skills. Word processing knowledge and experience with Microsoft Office products.