Lead – Document Control

Eli Lilly and Company•Pleasant Prairie, WI

5d•$27 - $44•Onsite

About The Position

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 technical writers 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 Technical Writer serves as a site author 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 Technical Writer is responsible for assisting in the development, optimization, and maintenance of GxP Procedural Documents, Protocols and Investigations to ensure compliance with FDA regulations and company policies and procedures. This role provides services in QA Initiatives and Cross Functional projects. Additionally, this role is responsible for the authoring, format, review, routing, distribution and filing of GXP documentation. This position requires a thorough knowledge of computer applications in the Microsoft Office Suite and established QMS applications.

Requirements

High School Diploma or GED or college BA/BS.
3 to 5 years in a regulated environment.
Thorough knowledge of Document Management practices and principles in a Corporate and regulated 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 quality work under short deadlines.
Responsible for formatting and ensuring document correctness prior to submission for document control routing approval
Previous experience with Quality management systems such as Master Control, TrackWise and/or Veeva.
Experience in a GMP manufacturing environment.
On-site presence is required.

Nice To Haves

Undergraduate degree in progress, Associate or Bachelor’s degree.
Change Control Authoring experience and Deviation investigation writing experience is a desired.
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.

Responsibilities

Creating and revising standard operating procedures, work instructions, forms, and other controlled documents to communicate complex technical information in a clear and concise manner.
Perform gap assessments between global and local procedures to identify areas that require remediation or continuous improvement.
Utilize completed gap assessments to revise or create controlled documents.
Collaborating with subject matter experts and technical staff to create or revise controlled documentation.
Ensuring that the written content meets the needs of its intended audience.
Responsible and accountable for the timely closure of assigned quality records.
Serve as document administrator within the electronic Quality Management System (eQMS), MasterControl and Veeva Quality Docs.
Process document changes and management of changes while ensuring good documentation practices (GDP).
Perform initial change control requests for proper workflow and change control documentation requirements within EDMS.
Act as contact person for troubleshooting record workflow through EDMS (Master Control, Quality Dos) document change management process.
Manage and ensure compliance to record retention policy.
Schedule and track the periodic review of controlled documents.
Maintain and issue logbooks to Operations, Engineering, Micro/QC Laboratories as needed.
Maintain, issue, and reconcile serialized forms.
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.
Other duties as assigned.

Benefits

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).

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