Senior Specialist - Document Control

Eli Lilly and Company; Pleasant Prairie (WI); On-site; Full time

Job summary

A global healthcare leader seeks a Senior Specialist – Document Control to manage GxP documentation and ensure compliance within the Quality Management System. This role offers a chance to contribute to new manufacturing investments and requires experience in a GMP environment, strong document management skills, and effective communication abilities.

Qualifications

• 3-5 years in a GMP environment.
• Strong knowledge of Document Management in a GMP setting.
• Effective interpersonal skills and ability to handle multiple tasks.

Responsibilities

• Coordinate Document Control activities and update Standard Operating Procedures.
• Assist with document initiation, review, and approval processes.
• Support internal audits and maintain electronic tracking of document approvals.

Skills

Interpersonal skills

Document Management

Technical writing

Education

High School Diploma or GED

Progress toward undergraduate degree or higher

Tools

Microsoft Office

Master Control

TrackWise

Veeva

Veeva Quality Docs

Smartsheet

Job description

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees work worldwide to discover and deliver life-changing medicines, improve disease management, and contribute to our communities through philanthropy and volunteerism. We prioritize putting people first and are seeking individuals committed to making a positive impact globally.

Position Overview:

Lilly is expanding its manufacturing capabilities globally to meet patient needs and support our future growth. We are seeking experienced Quality Assurance Associates to support our operations in Lilly Kenosha County (LKC). This role offers an excellent opportunity to be part of new manufacturing investments and pioneering technologies.

Role Summary:

The Senior Specialist – Document Control acts as the site document controller, managing GxP documentation and records within the Quality Management System (QMS) under the Central Quality Systems organization. This role ensures compliance with FDA regulations and company policies, supporting the site in delivering safe and effective products.

Key Responsibilities:

1. Coordinate Document Control activities at the designated Documentation Center.
2. Update Standard Operating Procedures as needed.
3. Assist with document initiation, review, and approval processes.
4. Manage documentation packages through review and approval cycles.
5. Support internal audits, investigations, and corrective actions related to documentation.
6. Maintain electronic tracking of document approvals and ensure the e-library is current.
7. Distribute approved documents, track receipt, and manage distribution matrices, including serialized forms.
8. Conduct periodic Documentation Binder Audits to verify documentation accuracy and completeness.
9. Issue controlled documentation to manufacturing and laboratory notebooks, maintaining issuance records.
10. Label and organize files in Documentation Centers.
11. Uphold ethics and compliance standards, reporting issues promptly, and attending cGMP training.
12. Lead departmental projects aimed at process optimization.

Minimum Requirements:

• High School Diploma or GED; college degree preferred.
• 3-5 years in a GMP environment.
• Strong knowledge of Document Management in a GMP setting.
• Effective interpersonal skills and ability to handle multiple tasks in a fast-paced environment.
• Proficiency with Microsoft Office applications.
• Experience in GMP manufacturing; on-site presence required.

Preferred Skills:

• Progress toward undergraduate degree or higher.
• Excellent communication and technical writing skills.
• Experience with serialization and Quality Management Systems like Master Control, TrackWise, Veeva.
• Knowledge of Veeva Quality Docs and Smartsheet.

Additional Information:

• Location: Kenosha County, Wisconsin.
• Travel: Approximately 10%.
• Overtime may be required.

This description provides a general overview; responsibilities may evolve. For significant changes, updates will be made accordingly. For accommodations during the application process, please visit this link. Lilly is an Equal Opportunity Employer and values diversity and inclusion.

Our employee resource groups include various affinity groups supporting diverse communities and interests. Learn more about our groups and initiatives.

Compensation for this role ranges from $28.12 to $46.88 per hour, depending on experience and location, with eligibility for bonuses and comprehensive benefits.