Technical Writer

$62,400 - $62,400/Yr

Medasource - Pleasant Prairie, WI

Full-time - Mid Level

Pleasant Prairie, WI

Waste Management and Remediation Services

About the position

The Technical Writer position at Eight Eleven Group focuses on supporting Parenteral Operations by producing high-quality technical documents. This role involves researching, organizing, writing, editing, and formatting various types of documentation, including standard operating procedures (SOPs), work instructions, and forms. The primary objective is to communicate complex technical information clearly and concisely to meet the needs of the intended audience. The Technical Writer will perform gap assessments between global and local procedures to identify areas for improvement and ensure compliance with Nexus Pharmaceutical's procedures. In this role, the Technical Writer will collaborate with subject matter experts and technical staff to create or revise controlled documentation. They will be responsible for the timely closure of assigned quality records and will serve as the document administrator within the electronic Quality Management System (eQMS), specifically using MasterControl. This includes processing document changes, managing change control documentation, and ensuring good documentation practices are followed. The Technical Writer will also perform document control reviews, launch new documents, and manage compliance with record retention policies. The position requires a strong attention to detail and the ability to work independently while maintaining strong organizational skills. The Technical Writer will also be expected to maintain and issue logbooks and serialized forms as needed, along with other duties as assigned. This is a contract position with a day shift schedule, primarily working Monday through Friday, with the potential for overtime and weekend work as required.

Responsibilities

• Provide support for Parenteral Operations by researching, organizing, writing, editing, and formatting technical information to produce high-quality documents.
• Create and revise standard operating procedures, work instructions, forms, and other controlled documents to communicate complex technical information clearly.
• Perform gap assessments between global and local procedures to identify areas requiring 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.
• Responsible for the timely closure of assigned quality records.
• Serve as document administrator within the electronic Quality Management System (eQMS), MasterControl.
• Process document changes and manage changes while ensuring good documentation practices (GDP) within the eQMS, MasterControl, and compliance to Nexus Pharmaceutical's procedures.
• Perform initial change control requests for proper workflow and change control documentation requirements within MasterControl.
• Act as contact person for troubleshooting record workflow through MasterControl change control process.
• Perform document control review following area manager and QA approval to ensure proper formatting.
• Launch new documents within MasterControl to assist with document change control lifecycles.
• 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.
• Other duties as assigned.

Requirements

• 4-year bachelor's degree in a science-related field strongly preferred (Additional GMP Quality Experience may be accepted in lieu of degree).
• 3+ years of relevant experience, preferably in the pharmaceutical industry.
• Knowledge of Microsoft Office Suite Programs required.
• Familiarity with digital QMS systems, MasterControl preferred.
• Quality minded, critical thinking, technical writing, problem solving, highly detail-oriented, and highly organized.

Nice-to-haves

• Experience in investigative techniques.
• Ability to communicate clearly and concisely when conveying information, summarizing facts, asking questions, etc.
• Strong organizational skills.

Benefits

• Dental insurance
• Health insurance
• Vision insurance