Job Title: Technical Writer cGMP Manufacturing
Company: Intellectt Inc.
Location: Madison, WI
Employment Type: W2 Contract
Pay Rate: $40-45/hour
Work Arrangement: Onsite
Job SummaryWe are seeking a detail-oriented Technical Writer to prepare, edit, and format cGMP manufacturing batch records and related technical documentation. This role requires advanced Microsoft Word skills, including the ability to create, maintain, and troubleshoot complex templates.
The writer will convert information provided by subject matter experts into project-specific batch record templates and documents, ensuring accuracy, consistency, and compliance with site procedures and Good Documentation Practices.
Key Responsibilities- Prepare, edit, and revise batch production records, including solution preparation, column, and bulk-fill records.
- Create reusable templates and draft project-specific batch records using supplied technical information.
- Prepare platform documents and batch summary reports based on executed production records.
- Format and maintain complex technical documents using Word styles, tables, cross-references, and form fields.
- Incorporate review comments and work with subject matter experts to resolve feedback.
- Identify documentation gaps and improve templates, document structure, and consistency.
- Ensure documents meet applicable regulatory guidance, site SOPs, Good Documentation Practices, and project deadlines.
- Support Manufacturing Science and Technology (MS&T) documentation activities and related projects.
- Independently complete moderately complex assignments with a high degree of accuracy.
- Identify and escalate process abnormalities and documentation issues.
- Support junior team members and lead small documentation improvement projects as needed.
Required Skills and Experience- Experience preparing or supporting batch production records, SOPs, reports, or other regulated manufacturing documentation.
- Advanced Microsoft Word proficiency, particularly complex formatting, styles, tables, cross-references, and form fields.
- Proven ability to create, modify, maintain, and troubleshoot complex Word templates.
- Strong technical writing, editing, communication, and organizational skills.
- Exceptional attention to detail and commitment to document accuracy and quality.
- Proficiency in Microsoft Excel and PowerPoint, with the ability to troubleshoot common document issues.
- Ability to interpret detailed written, verbal, diagrammatic, and scheduled instructions.
- Strong prioritization and time-management skills, with the ability to manage a high volume of work and multiple deadlines.
- Ability to work independently and collaborate with cross-functional teams.
- Sound judgment, adaptability, and problem-solving skills.
- Availability to work onsite full-time in Madison, WI, with occasional overtime.
Preferred Qualifications- Experience in biologics or pharmaceutical manufacturing.
- Familiarity with cGMP documentation requirements and manufacturing workflows.
- Experience supporting MS&T teams and documentation improvement initiatives.
Key Skills:
cGMP Technical Writing, Batch Production Records (BPR), SOP Documentation, Advanced Microsoft Word, Complex Word Templates, Document Formatting, Styles, Tables, Cross-References, Form Fields, Batch Summary Reports, Platform Documents.
Recruiter Contact:
Rudra Prasad Kunnath
Email:
prasad.kunnath@intellectt.com
Phone: 732-200-2726 EXT 189Benefits: Employees hired into this position are eligible for benefits subject to applicable plan terms and eligibility requirements.
- Health Insurance: Medical, dental, and vision insurance options are available through a third-party provider. Employees are responsible for the full cost of insurance premiums.
- Retirement: A 401(k) retirement savings plan is available. No employer matching or other employer contributions are provided.
- Paid Time Off: No PTO is provided beyond what is required by applicable state and local laws.
Equal Employment Opportunity:
Intellectt Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, disability, genetic information, veteran status, or any other characteristic protected by applicable federal, state, or local law.