Document Control Specialist
Eli Lilly and Company
28 days ago
Remote friendly (Indianapolis, IN)
United States
Operations
Position Description
The Document Control Specialist supports global quality and process documentation by managing end-to-end document lifecycle activities in Veeva Vault QualityDocs (QDocs). This role coordinates review/approval workflows, ensures document and metadata accuracy, applies templates and standards, and helps maintain inspection readiness through timely processing, tracking, and reporting.
Key Objectives / Deliverables
- Execute timely, right-first-time processing of global process documents in Veeva Vault QualityDocs (QDocs) from draft through issuance and retirement.
- Maintain document lifecycle compliance and metadata accuracy to support training impact, searchability, reporting, and inspection readiness.
- Enable consistent global process documentation by applying templates/standards and providing writing and formatting support.
- Support team performance through metrics, continuous improvement, and proactive issue identification/escalation.
Major Responsibilities
- Coordinate review and approval cycles with document owners, reviewers, and approvers (communications, reminders, and status tracking).
- Apply and verify required document metadata/attributes (e.g., document type, process owner, applicability, training impact, and effective date rules); perform quality checks prior to approval.
- Support document change execution by ensuring revisions align with approved changes and impacted documents/stakeholders are identified for review.
- Monitor periodic review status and follow up with owners to ensure completion within required timeframes.
- Support audit/inspection readiness through document/record retrieval, basic metrics/reporting, and proactive identification of document or metadata issues.
- Partner with Quality, Learning & Development, and stakeholders to align documents with training and process needs; provide backup support across the team as needed.
Basic Qualifications
- High School Diploma/GED required; Associate’s degree or higher preferred. 2+ years of experience in document control/records management, quality systems, or regulated documentation support (pharmaceutical/biotech/medical device preferred).
- Hands-on experience in Veeva Vault QualityDocs (QDocs) and Microsoft Office (Word, Excel, Outlook).
Additional Skills / Preferences
- Knowledge of controlled documentation/records practices in a regulated environment (GMP/GDP concepts and data integrity expectations).
- Strong attention to detail and ability to perform right-first-time document and metadata checks.
- Strong written communication skills; ability to edit for clarity and consistent standard work language.
- Ability to manage multiple priorities, meet deadlines, and maintain organized tracking.
- Problem-solving skills to troubleshoot workflow issues and coordinate resolution across stakeholders.
- Customer-focused, collaborative approach; comfortable partnering with global stakeholders across time zones.
- Experience with basic metrics/reporting (Excel) and continuous improvement methods preferred.
Compensation & Benefits
- Anticipated wage: $65,250 - $148,500.
- Full-time equivalent employees may be eligible for a company bonus (depending on company and individual performance).
- Comprehensive benefit program (e.g., 401(k), pension, vacation, medical/dental/vision/prescription drug benefits, flexible benefits, life insurance/death benefits, certain time off/leave of absence, well-being benefits such as employee assistance program, fitness benefits, employee clubs/activities).
The Document Control Specialist supports global quality and process documentation by managing end-to-end document lifecycle activities in Veeva Vault QualityDocs (QDocs). This role coordinates review/approval workflows, ensures document and metadata accuracy, applies templates and standards, and helps maintain inspection readiness through timely processing, tracking, and reporting.
Key Objectives / Deliverables
- Execute timely, right-first-time processing of global process documents in Veeva Vault QualityDocs (QDocs) from draft through issuance and retirement.
- Maintain document lifecycle compliance and metadata accuracy to support training impact, searchability, reporting, and inspection readiness.
- Enable consistent global process documentation by applying templates/standards and providing writing and formatting support.
- Support team performance through metrics, continuous improvement, and proactive issue identification/escalation.
Major Responsibilities
- Coordinate review and approval cycles with document owners, reviewers, and approvers (communications, reminders, and status tracking).
- Apply and verify required document metadata/attributes (e.g., document type, process owner, applicability, training impact, and effective date rules); perform quality checks prior to approval.
- Support document change execution by ensuring revisions align with approved changes and impacted documents/stakeholders are identified for review.
- Monitor periodic review status and follow up with owners to ensure completion within required timeframes.
- Support audit/inspection readiness through document/record retrieval, basic metrics/reporting, and proactive identification of document or metadata issues.
- Partner with Quality, Learning & Development, and stakeholders to align documents with training and process needs; provide backup support across the team as needed.
Basic Qualifications
- High School Diploma/GED required; Associate’s degree or higher preferred. 2+ years of experience in document control/records management, quality systems, or regulated documentation support (pharmaceutical/biotech/medical device preferred).
- Hands-on experience in Veeva Vault QualityDocs (QDocs) and Microsoft Office (Word, Excel, Outlook).
Additional Skills / Preferences
- Knowledge of controlled documentation/records practices in a regulated environment (GMP/GDP concepts and data integrity expectations).
- Strong attention to detail and ability to perform right-first-time document and metadata checks.
- Strong written communication skills; ability to edit for clarity and consistent standard work language.
- Ability to manage multiple priorities, meet deadlines, and maintain organized tracking.
- Problem-solving skills to troubleshoot workflow issues and coordinate resolution across stakeholders.
- Customer-focused, collaborative approach; comfortable partnering with global stakeholders across time zones.
- Experience with basic metrics/reporting (Excel) and continuous improvement methods preferred.
Compensation & Benefits
- Anticipated wage: $65,250 - $148,500.
- Full-time equivalent employees may be eligible for a company bonus (depending on company and individual performance).
- Comprehensive benefit program (e.g., 401(k), pension, vacation, medical/dental/vision/prescription drug benefits, flexible benefits, life insurance/death benefits, certain time off/leave of absence, well-being benefits such as employee assistance program, fitness benefits, employee clubs/activities).