Job Title: Technical Writer Pharma
Location: Onsite Wisconsin
Employment Type: Contract 6+ Months
Job Responsibilities:
- Assist in the preparation, editing, and revision of cGMP manufacturing batch production records, including solution, column, and bulk-fill records.
- Develop and maintain batch record templates using information provided by subject matter experts and project teams.
- Prepare platform documents and batch summary reports based on manufacturing execution records.
- Format, edit, and maintain complex technical documents, templates, and related manufacturing documentation.
- Incorporate internal comments and collaborate with subject matter experts to review and resolve documentation feedback.
- Identify documentation gaps and recommend improvements to existing templates and documents.
- Ensure all documentation complies with applicable regulatory guidance, site SOPs, Good Documentation Practices (GDP), and project timelines.
- Support technical writing activities and other Manufacturing Science & Technology (MS&T) projects as assigned.
Required Qualifications:
- Associate degree in a STEM discipline with more than 6 years of related experience; or
- Bachelor's degree in a STEM discipline with 3 6 years of related experience; or
- Master's degree in a STEM discipline with 0 2 years of related experience.
- Proficiency in Microsoft Excel, PowerPoint, and common document troubleshooting tasks.
- Experience supporting batch production records, SOPs, technical reports, or other regulated manufacturing documentation.
- Strong time-management, prioritization, and multitasking skills, with the ability to manage high volumes of work and meet multiple deadlines.
- Experience leading small team projects and identifying opportunities for process improvement.
- Biologics or pharmaceutical manufacturing experience is preferred.
Pay Scale Anticipated hourly pay rate: $45/hr to $48/hr W2 (Maximum), depending on experience (DOE).
Benefits Employees hired into this position may be eligible for benefits, subject to applicable plan terms and eligibility requirements:
- Health Insurance: Medical, dental, and vision insurance options may be available through a third-party provider. Employees may be responsible for some or all of their insurance premiums, depending on the applicable plan.
- Retirement Benefits: A 401(k) retirement savings plan may be available, subject to plan eligibility and applicable terms.
- Paid Time Off (PTO): PTO eligibility is subject to the applicable employment agreement and state and local requirements.