Document Controller

Document ControllerDuration: 18 month contractHours: 8:00am to 5:00pm Monday to FridayLocation: Onsite in Indianapolis, INPay Range: $35.00 - $41.00The experienced Document Controller supports the GQC QA Operations team by managing the full lifecycle, control, and governance of quality documentation required for compliance with Global Quality Standards (GQS), Lilly Quality Standards (LQS), and applicable departmental procedures. This role ensures documentation is consistently controlled, inspection-ready, and aligned with regulatory expectations, while providing subject matter expertise and guidance on document control processes across QA and site functions.Minimum Experience Requirements:Minimum 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 assessmentsEducational Requirements:Bachelor’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 functionsKey Responsibilities:Owns 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 complianceBenefits (employee contribution):Health insuranceHealth savings accountDental insuranceVision insuranceFlexible spending accountsLife insuranceRetirement planAll qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Rate of pay within the stated range will depend on the qualification of the applicant.