Access Control, Biotech and Pharmaceutical, Calibration, Capsules, Consulting, Control Systems, Corrective Action, Customer Support/Service, Data Quality, Detail Oriented, Documentation, GMP (Good Manufacturing Practices), Manufacturing, Manufacturing Operations, Medical Equipment, Organizational Skills, Preventative Maintenance, Quality Management, Software Testing, Source Code/Configuration Management (SCM), Standard Operating Procedures (SOP), Systems Administration/Management, Technical Writing, Writing Skills
GMP Technical Writer / SQA Specialist
Contract: 5 months duration with potential for extension
Location: Tampa, FL â onsite
Status: Full-time
Role Summary
ASI is seeking a GMP Technical Writer / SQA Specialist to support our clientâs 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
- 3â6+ 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