Lead Tech Writer -Doc Control

BioSpace; Pleasant Prairie (WI); On-site; USD 37,746 - 61,192; Full time

Benefits offered by this job

401(k)

Pension

Medical/Dental/Vision coverage

Vacation benefits

Wellness programs

Job summary

A leading global biopharmaceutical company in Kenosha County, Wisconsin, is seeking a Senior Technical Writer to support GxP documentation for its Quality Management System (QMS). The ideal candidate will possess skills in technical writing and document management, with a minimum of 3 to 5 years' experience in a regulated environment preferred. This role involves creating standard operating procedures and collaborating with experts to ensure compliance with regulatory requirements. A comprehensive benefits package is offered, including a competitive hourly rate and potential bonuses.

Qualifications

• 3 to 5 years in a regulated environment.
• Thorough knowledge of Document Management practices.
• Ability to learn different computer systems.

Responsibilities

• Create and revise standard operating procedures.
• Perform gap assessments for compliance.
• Collaborate with subject matter experts.

Skills

Technical writing

Interpersonal skills

Document management

Microsoft Office Suite

Attention to detail

Education

High School Diploma or GED or college BA/BS

Tools

MasterControl

TrackWise

Veeva Quality Docs

Job description

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, formatting, 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.

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.
• Collaborate with subject matter experts and technical staff to create or revise controlled documentation.
• Ensure that the written content meets the needs of its intended audience.
• Be responsible and accountable for the timely closure of assigned quality records.
• Serve as the document administrator within the electronic Quality Management System (eQMS), MasterControl and Veeva Quality Docs.
• Process document changes and manage changes while ensuring good documentation practices (GDP).
• Perform initial change‑control requests for proper workflow and documentation requirements within EDMS.
• Act as the contact person for troubleshooting record workflow through EDMS (MasterControl, Quality Docs) in the document change‑management process.
• Manage and ensure compliance with the 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 an ethics and compliance commitment. Report and address compliance issues in a timely manner. Attend cGMP training programs as required.
• Participate in department optimization efforts; lead selected projects and assignments, following them through to closure.
• Other duties as assigned.

Basic 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 have a working knowledge of Microsoft (e.g., Excel, Word).
• Ability to prioritize work and 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 MasterControl, TrackWise and/or Veeva.
• Experience in a GMP manufacturing environment.
• On‑site presence is required.

Additional Skills/Preferences

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

Additional Information

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

Compensation and Benefits

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $27.40 – $44.42 per hour. Full‑time equivalent employees will also be eligible for a company bonus (depending, in part, on company and individual performance). Lilly offers a comprehensive benefit program, including 401(k), pension, vacation benefits, medical/dental/vision coverage, flexible benefits, life insurance, leave‑of‑absence benefits, and wellness programs.

EEO and Disability Accommodations

Lilly is dedicated to helping individuals with disabilities engage in the workforce, ensuring equal opportunities. If you require accommodation to submit a resume, complete the accommodation request form at https://careers.lilly.com/us/en/workplace-accommodation. Lilly is a proud 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.