GMP Technical Writer / SQA Specialist

GMP Technical Writer / SQA Specialist

Status: Full-time

Role Summary

ASI is seeking a GMP Technical Writer / SQA Specialist to support our client’s oral solid dose manufacturing operations in Tampa. The role will provide documentation and quality-system support for equipment, utilities, and facilities used in the manufacture of tablets, capsules, and powder-based products, with particular emphasis on calibration and maintenance remediation. This role will also support deviations, investigations, CAPAs, and computerized-system access controls.

Key Responsibilities

• Author and revise GMP documents, including SOPs, Work Instructions, deviations, investigations, CAPAs, and maintenance and calibration procedures
  


• Work with Maintenance, Calibration, Engineering, Operations, and Quality personnel to gather technical content and convert it into clear, GMP-compliant documentation
  


• Support investigation writing, root-cause documentation, corrective actions, and closure of quality-system records
  


• Review and update preventive maintenance and calibration documentation for accuracy, completeness, and alignment with current practices
  


• Maintain trackers for open documents, investigations, CAPAs, calibration items, maintenance actions, and approval status
  


• Catalog computerized systems and online software platforms used across the site
  


• Review, document, and update user access, security roles, permissions, and system ownership
  


• Support periodic access reviews and removal of inactive, duplicate, or inappropriate access
  


• Coordinate document routing, review, approval, and effective-date activities within applicable electronic quality systems
  


• Support inspection-readiness and documentation-remediation initiatives
  

Requirements

Requirements

Required Qualifications

• 3–6+ years of GMP technical writing experience in pharmaceutical, biotech, or medical-device manufacturing
  


• Demonstrated experience authoring SOPs, Work Instructions, deviations, investigations, and CAPAs
  


• Experience supporting calibration, maintenance, engineering, or equipment-related documentation
  


• Familiarity with electronic quality-management and document-control systems
  


• Strong understanding of GMP documentation, data integrity, version control, and approval workflows
  


• Ability to translate complex technical information into clear, compliant, and auditable documents
  


• Strong organizational skills and attention to detail