New

Documentation & Change Control Specialist

Spectraforce Technologies

Apr 15, 2026
Job Title: Documentation & Change Control Specialist Location: Branchburg, NJ 08876 (100% Onsite- Candidates must be local (relocation is not supported for this duration). Duration: 6 Months Position Summary: The Documentation Specialist is a critical hybrid responsible for the end-to-end lifecycle of controlled quality documentation and low-impact change management. This individual will act as a "Gatekeeper" for quality, ensuring all procedures, forms, specifications, and test methods are processed, edited, and routed in strict accordance with Good Manufacturing Practices (GMP). This role is roughly balanced between Electronic Document Management (50-60%) and Change Control Management (approx. 30%), requiring high-level coordination with engineers, medical experts, and quality teams. Key Responsibilities: Document Control: Process, verify, and route documents within the Electronic Document Management System (EDMS). Template Compliance: Review technical documents to ensure strict adherence to proper templates and formatting standards. Workflow Management: Monitor and drive the document review process, ensuring all cross-functional reviewers (Quality, Engineering, Medical) complete their tasks within the system. Change Management: Act as a "Change Manager" within the electronic system (OneTrack/TrackWise) to evaluate and move low-impact changes through the lifecycle. Technical Writing: Perform minor technical writing tasks, including updating local documents and modifying content based on stakeholder feedback. Stakeholder Collaboration: Provide polite, constructive, and positive feedback to authors and reviewers to maintain a collaborative, high-performing team environment. Required Qualifications & Experience: Education: Bachelor's degree with 3+ years of professional experience OR an associate's degree with 5+ years of experience in Documentation/Change Control. (Equivalent high-level experience will be considered for contract eligibility. Industry Experience: Pharmaceutical or Medical Device industry is highly preferred/mandatory. System Expertise (Veeva): Significant experience with Veeva OneVault (Veeva Quality Docs) is strongly preferred. Candidates with Veeva experience will be prioritized. Change Control Systems: Familiarity with OneTrack (TrackWise on the Salesforce platform) or legacy TrackWise is highly beneficial. Software Proficiency: Expert-level knowledge of MS Word (formatting, track changes, templates) and general MS Office Suite. Core Competencies: Multi-Tasking: Proven ability to manage multiple parallel document reviews and priorities with minimal supervision. Communication: Exceptional verbal and written communication skills, with the ability to navigate diverse personalities across different functional areas. GMP Knowledge: Thorough understanding of Good Manufacturing Practices and quality system documentation.