Eli Lilly and Company · 10 hours ago
Lead Tech Writer -Doc Control
Pleasant Prairie, WI
Full-time
Onsite
Mid, Senior Level
$28.84/hr - $46.54/hr
3+ years expEli Lilly and Company is a global healthcare leader headquartered in Indianapolis, Indiana, focused on improving lives through innovative medicines. They are seeking a Lead Tech Writer to support GxP Documentation and records for their Quality Management System, ensuring compliance with FDA regulations and company policies while collaborating with various stakeholders to produce clear and concise technical documentation.
BiotechnologyHealth CareMedicalPharmaceutical
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
Qualification
Required
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
Preferred
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
Benefits
Company bonus
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
Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)
Company
Eli Lilly and Company
We're a medicine company turning science into healing to make life better for people around the world.
10001+ employees
H1B Sponsorship
Eli Lilly and Company has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (514)
2024 (236)
2023 (167)
2022 (133)
2021 (57)
2020 (52)
Funding
Current Stage
Public CompanyTotal Funding
$6.5M2024-02-12Post Ipo Debt· $6.5M
1978-01-13IPO
Leadership Team
David Ricks
Chair, CEO
Lucas Montarce
Executive Vice President and Chief Financial Officer
Recent News
2026-01-12
2026-01-12
Company data provided by crunchbase