Document Controller

System One, Inc.; Indianapolis (IN); Presencial; USD 48.000 - 57.000; Jornada completa

Descripción de la vacante

System One, Inc. is seeking a Document Controller in Indianapolis, IN for an 18-month contract on-site. The role requires managing the end-to-end document control lifecycle for QA documentation in a regulated environment, with a strong emphasis on accuracy and regulatory compliance.

The position offers hourly compensation and potential extension or conversion. Responsibilities include supporting inspections, maintaining controlled repositories, and driving improvements in document control

Formación

• 4+ years of experience in document control within a regulated (GxP) pharmaceutical or biotech environment.
• Experience using Veeva QualityDocs for controlled documents is required.
• Experience supporting inspections, audits, periodic reviews, and documentation gap assessments.
• Bachelor’s degree or equivalent experience.

Responsabilidades

• Owns and manages end-to-end document control lifecycle for QA documentation per GQS/LQS.
• Provides subject matter expert guidance on document control standards and processes.
• Reviews QA docs for accuracy, formatting, and regulatory compliance.
• Leads periodic reviews and gap assessments, identifying risks and remediation needs.
• Coordinates routing of documents through review/approval workflows.

Conocimientos

Document control

QA documentation

Regulatory compliance

Attention to detail

Communication skills

Independent worker

Educación

Bachelor's degree

Herramientas

Veeva QualityDocs

Descripción del empleo

Job Title: Document Controller

Location: Indianapolis, IN

Hours: Mon - Fri 8am - 5pm, onsite

Compensation: $34.95 - $41.10/hr

Type: 18-month contract, Potential for extension or conversion to permanent

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 requirements
• Provides subject matter expertise on document control standards, processes, and best practices to QA and cross-functional partners
• Reviews QA documentation for accuracy, completeness, formatting, and compliance with quality standards and regulatory expectations
• Leads and supports periodic review and gap assessment activities, identifying documentation gaps, risks, and remediation needs
• Coordinates and facilitates document routing through electronic or manual review and approval workflows, ensuring timely execution
• Maintains controlled document repositories to ensure documents are current, traceable, and readily accessible for operations and inspections
• Tracks, monitors, and reports documentation status, metrics, and deliverables to QA Operations leadership
• Supports inspection readiness activities by ensuring controlled documents are inspection-ready and aligned with site practices
• Partners with QA and operational stakeholders to support documentation strategies for new processes, changes, and remediation efforts
• Identifies opportunities to improve document control efficiency, consistency, and compliance

Requirements

• Minimum of 4 years of experience in document control within a regulated (GxP) pharmaceutical or biotechnology environment
• Demonstrated hands-on experience managing controlled documents using Veeva QualityDocs (required)
• Experience supporting inspections, audits, periodic reviews, and documentation gap assessments
• Bachelor’s degree or equivalent experience
• Strong written and verbal communication skills
• Detailed knowledge of Quality policies, procedures, and document control principles
• Strong attention to detail, organizational skills, and ability to manage multiple priorities
• Proven ability to work independently and influence across functions

System 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-Scientific