Qualifications

• 3-6+ years of GMP technical writing in pharmaceuticals, biotech, or medical devices
• Experience with authoring SOPs, Work Instructions, and CAPAs
• Knowledge in calibration and maintenance documentation
• Familiarity with electronic quality management systems
• Understanding of GMP documentation standards and approval workflows
• Ability to simplify complex technical data into compliant documents
• Strong attention to detail and organizational skills

Responsibilities

• Author and update GMP documents like SOPs and investigations
• Collaborate with various departments to gather technical content
• Support investigations and document root-cause analysis
• Ensure preventive maintenance and calibration documents are accurate
• Maintain trackers for documents and quality system items
• Catalog computerized systems used on-site
• Manage user access and security roles within systems
• Help ensure readiness for inspections and document initiatives

Benefits

• Potential for contract extension beyond 5 months
• Onsite role providing immediate interaction with teams
• Opportunity to support a variety of GMP documentation tasks
• Hands-on involvement in quality system remediation and compliance efforts
• Ability to work within a respected pharmaceutical environment