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Coordinator - Document Control Quality Systems-FDE
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 39,000 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.
Responsible for the review, routing, distribution, labeling and filing of GXP documentation. Update and maintain document tracking databases and archival systems. Administer Documentation Audit programs for GXP documents. This position requires a thorough knowledge of computer applications in the Microsoft Office Suite; including scanning of documentation. Some physical movement of document files/boxes is required; must be able to lift 30 pounds.
Prepare and route documentation packages throughout review and approval cycle.
Track document approval activities in electronic tracking system; ensuring on-line e-library is updated and accurate.
Distribute approved documentation to appropriate personnel, track receipt of documentation, and maintain distribution matrices.
Initiate and track periodic Documentation Binder Audits to assure documentation in the field is current and complete.
Issue controlled Production Documentation to Manufacturing and Laboratory Notebooks to cross functional areas; maintain records of issuance.
Label and code files for storage in on-site Documentation Centers.
Ensure ethics and compliance commitment at all times. Report/Address compliance issues in a timely manner. Attend cGMP training programs as required.
HS/ GED with a minimum of 3 years of experience in the pharmaceutical/biopharmaceutical industry or related sciences industry with GxP systems or
Completion of Post Offer Exam, Completion of Work Simulation or Completion of Administrative Skills Testing if applicable.
Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.
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.
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