Specialist

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 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 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 On-site presence required.
• 2 to 4 years of relevant experience in the pharmaceutical/biopharmaceutical industry is required; specific GXP-regulated documentation control experience is required.
• Thorough knowledge of Document Management practices and principles in a Corporate and GMP 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.
• Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.
• Ability to compile data and metrics in reports understandable by management and business partners.
• Previous experience with serialization, Quality management systems such as Master Control, TrackWise and/or Veeva.

Additional Information:

• Primary location is Kenosha County, Wisconsin
• Ability to travel (approximately 10 %)
• Ability to work overtime as required.

This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. For GMP purposes, the job description should be updated for significant changes. As always, you should consult with your supervisor regarding your actual job responsibilities and any related duties that may be required for the position.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, 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 are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.