Technical Writer – cGMP Manufacturing

Intellectt INC
  • Madison, WI
  • Instant Apply
4 days ago

Job Description

Job Title: Technical Writer cGMP Manufacturing
Company: Intellectt Inc.
Location: Madison, WI 100% Onsite
Duration: 6+ Months

Pay Range: $40 - $45/hr on W2

Job Summary

Seeking an experienced Technical Writer to create, edit, and maintain cGMP manufacturing batch records, SOPs, and technical documents. Must have advanced Microsoft Word skills and experience creating and managing complex document templates.

Key Responsibilities

  • Prepare and revise GMP batch production records and manufacturing documents.
  • Create and maintain complex Microsoft Word templates.
  • Prepare batch summary reports and platform documents.
  • Format documents using Word styles, tables, cross-references, and form fields.
  • Coordinate with SMEs to incorporate technical information and review comments.
  • Ensure documentation complies with cGMP, SOPs, and Good Documentation Practices (GDP).

Required Skills

  • Experience with batch production records, SOPs, and regulated manufacturing documentation.
  • Advanced Microsoft Word proficiency mandatory.
  • Hands-on experience creating and troubleshooting complex Word templates.
  • Strong technical writing, editing, and documentation skills.
  • Knowledge of cGMP and Good Documentation Practices.
  • Proficiency in Microsoft Excel and PowerPoint.
  • Strong attention to detail and ability to manage multiple deadlines.

Preferred Qualifications

  • Pharmaceutical or biologics manufacturing experience.
  • Familiarity with MS&T documentation and manufacturing workflows.

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.

Benefits: Employees hired into this position are eligible for the following benefits, subject to the 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 paying the full cost of their insurance premiums.

Retirement Benefits: A 401(k)retirement savings plan is available. No employer matching or other employer contributions are provided.

Paid Time Off (PTO): No PTO other than that required by applicable state and local laws.

Thanks & Regards,
Mahalakshmi
Junior Recruiter
Intellectt Inc

mahalakshmi.n@intellectt.com


+1 (732) 737 8381

Numbers & Facts

LocationMadison, WI

Skills

  • Current Good Manufacturing Practice (cGMP)unmatched
  • Detail Orientedunmatched
  • Document Managementunmatched
  • Documentationunmatched
  • Documentation Formatunmatched
  • Drug Manufacturingunmatched
  • Editingunmatched
  • Employee Benefitsunmatched
  • GMP (Good Manufacturing Practices)unmatched
  • Identify Issuesunmatched
  • Manufacturingunmatched
  • Microsoft Excelunmatched
  • Microsoft PowerPointunmatched
  • Microsoft Wordunmatched
  • Standard Operating Procedures (SOP)unmatched
  • Technical Editingunmatched
  • Technical Writingunmatched
  • Time Managementunmatched
  • Writing Skillsunmatched

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