Senior Specialist - Document Control

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 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.

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 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.

Position Overview:

Lilly is actively growing its manufacturing footprint globally to meet the needs of patients and deliver on our exciting future.  As a result, Lilly is looking for experienced quality assurance associates to support our growth in Lilly Kenosha County (LKC). This is an outstanding opportunity to deliver on new manufacturing investments and new pioneering technologies.

The Senior Specialist – Document Control serves as a site document controller to support GxP Documentation and records for the Quality Management System (QMS) under the Central Quality Systems organization which enables the LKC site to provide safe and effective products and to meet customer expectations and regulatory requirements.   

The Senior Specialist – Document Control is responsible for assisting in the development, optimization, and maintenance of Document Control systems to ensure compliance with FDA regulations and company policies and procedures. This role represents Document Control in QA Initiatives and Cross Functional projects.  Additionally, this role is responsible for the review, routing, distribution and filing of GXP documentation.  This position requires a thorough knowledge of computer applications in the Microsoft Office Suite.

Responsibilities:

• Assist in the coordination of Document Control activities in a specified Documentation Center location.
• Update departmental Standard Operating Procedures as needed.
• Provide technical assistance throughout the document initiation, review, and approval process.
• Prepare and route documentation packages throughout review and approval cycle.
• Assist in departmental related internal audits, NCE investigations and corrective actions.
• 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.  Manage serialized forms.
• 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.
• Always ensure ethics and compliance commitment. Report/Address compliance issues in a timely manner. Attend cGMP training programs as required.
• Participate in department optimization efforts; take the lead on selected projects and assignments, following them through to closure.

Basic Requirements:

• High School Diploma or GED or college BA/BS.
• 3 to 5 years in a GMP environment.
• Thorough knowledge of Document Management practices and principles in a Corporate and GMP environment.
• Establish positive interpersonal relationships and interact effectively with people.
• Work with multiple assignments at a time and within a fast-paced environment.
• Ability to learn different computer systems and work knowledge of Microsoft (e.g. Excel, Word).
• Ability to prioritize work and to deliver under short deadlines.
• Experience in a GMP manufacturing environment.
• On-site presence is required.

Additional Skills/Preferences:

• Undergraduate degree in progress, Associate or Bachelor’s degree.
• Demonstrated strong oral and written communication and interpersonal interaction skills.
• Demonstrated strong technical writing skills.