Document Controller - Quality Assurance

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 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

The Document Controller, Quality Assurance (QA) is responsible for electronic documentation and records management oversight at Lilly's Research Triangle Park, North Carolina site. This role is responsible for execution, maintenance, and administration of document management systems. The Document Controller will aid in initial program startup and routine operation of the site, as well as support site inspection readiness and execution.

Responsibilities:

The Document Controller, Quality Assurance, will aid in start-up and routine operation of the GMP document and records management program execution at Lilly's pharmaceutical manufacturing site.

• Maintain GMP Library document inventory control through the Lilly Record Manager (LRM) system.
• Maintain Doc Controller role for all documents and records maintained in Veeva Quality Docs Electronic Data Management System (EDMS).
• Ensure Lilly training and compliance to global and local Documentation and Records Management requirements.
• Assists in support of processes for updating, routing, and approval of electronic documents by appropriate Lilly personnel.
• Day to day management and monitoring of assigned Veeva Vault QualityDocs workflows.
• Meet with Lilly internal personnel to review documents and assign Veeva Quality Docs meta data when adding documents into the Veeva Quality Docs EDMS.
• Manage Retention of GMP Related Records in accordance with Document Type and Record Class Codes (RCC). This includes shipment of GMP records to External storage location for long term retention as necessary.
• Manage and facilitate reconciliation process for executable records.
• Support external and internal audits through providing readily accessible records as requested for review by Regulatory Agency and Notified bodies, and/or Lilly internal auditing and compliance groups.
• Support Site Self Inspections associated with Document Control and the Veeva Vault Q Docs Electronic Data Management System (EDMS).
• Monitor and ensure that document periodic reviews are performed within Veeva Vault QualityDoc according to Lilly standards.
• Follow up with document owners to ensure review and updating on a timely basis
• Work closely with Quality, Learning and Development, and other Lilly functions to ensure their document needs are captured as required.

Basic Requirements:

• High school diploma or GED

Additional Skills/Preferences:

• Experience with Microsoft Office (Outlook, Work, & Excel)
• Previous experience in records management, data entry, or similar experience
• Demonstrated ability to work successfully in a team environment
• Demonstrated Project Management skills
• Strong written and verbal communication skills
• Strong ability to solve problems and make decisions
• Experience with documentation in a GMP environment and electronic tracking of document
• Experience in quality systems such as TrackWise, Veeva Vault QualityDocs

Additional Information:

• Ability to work 8-hour days – Monday through Friday Day shift; Onsite
• Some overtime may be required to support audits as necessary and will be compensated for overtime

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company (subject to applicable law). 

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