Document Controller

Job Title: Document ControllerLocation: Indianapolis, INHours: Mon - Fri 8am - 5pm, onsiteCompensation: $34.94 - $41.11/hrType: Contract, Potential for extension or conversion to permanentResponsibilitiesOwns and manages the end-to-end document control lifecycle for QA documentation, including creation, revision, review, approval, issuance, archiving, and retirement, in compliance with GQS and LQS requirementsProvides subject matter expertise on document control standards, processes, and best practices to QA and cross-functional partnersReviews QA documentation for accuracy, completeness, formatting, and compliance with quality standards and regulatory expectationsLeads and supports periodic review and gap assessment activities, identifying documentation gaps, risks, and remediation needsCoordinates and facilitates document routing through electronic or manual review and approval workflows, ensuring timely executionMaintains controlled document repositories to ensure documents are current, traceable, and readily accessible for operations and inspectionsTracks, monitors, and reports documentation status, metrics, and deliverables to QA Operations leadershipSupports inspection readiness activities by ensuring controlled documents are inspection-ready and aligned with site practicesPartners with QA and operational stakeholders to support documentation strategies for new processes, changes, and remediation effortsIdentifies opportunities to improve document control efficiency, consistency, and complianceRequirementsMinimum of 4 years of experience in document control within a regulated (GxP) pharmaceutical or biotechnology environmentDemonstrated hands-on experience managing controlled documents using Veeva QualityDocs (required)Experience supporting inspections, audits, periodic reviews, and documentation gap assessmentsBachelor's degree or equivalent experienceStrong written and verbal communication skillsDetailed knowledge of Quality policies, procedures, and document control principlesStrong attention to detail, organizational skills, and ability to manage multiple prioritiesProven ability to work independently and influence across functionsSystem One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.Ref: #558-ScientificSystem One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.