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Document Controller

Primary Talent Partners

Indianapolis, IN

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JOB DETAILS
SALARY
$36–$41 Per Hour
SKILLS
Best Practices, Biotech and Pharmaceutical, Communication Skills, Cross-Functional, Detail Oriented, Document Control, Document Management, Documentation, Documentation Standards, GxP, Multitasking, Operational Support, Organizational Skills, Presentation/Verbal Skills, Quality Assurance, Quality Metrics, Support Documentation, Time Management, Writing Skills
LOCATION
Indianapolis, IN
POSTED
3 days ago
Primary Talent Partners has a new contract opening for a Document Controller to join our pharmaceutical client in Indianapolis, IN. This is an 18-month contract to start with the potential for extensions. 

Pay:$36.00 - $41.00/hr; W2 contract, no PTO, no Benefits. ACA-compliant supplemental package available for enrollment. Candidates must be legally authorized to work in the United States and must be able to sit on Primary Talent Partners W2 without sponsorship.


Description:
The 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), Client Quality Standards, 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.


Key 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 QS 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


Minimum Experience 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


Educational Requirements:
  • 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


Primary Talent Partners is an Equal Opportunity / Affirmative Action employer committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, age, national origin, disability, protected veteran status, gender identity, or any other factor protected by applicable federal, state, or local laws.

If you are a person with a disability needing assistance with the application or at any point in the hiring process, please contact us at info@primarytalentpartners.com

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Primary Talent Partners

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