Document Control Specialist
Eli Lilly and Company
2 months 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).