Job Description
GMP Technical Writer / SQA Specialist
Contract: 5 months duration with potential for extension
Location: Tampa, FL - onsite
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
Requirements
Requirements
Required Qualifications
GMP Technical Writer / SQA Specialist
Contract: 5 months duration with potential for extension
Location: Tampa, FL - onsite
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, WorkInstructions, deviations, investigations, CAPAs, and maintenance andcalibration procedures
- Work with Maintenance, Calibration, Engineering,Operations, and Quality personnel to gather technical content and convertit into clear, GMP-compliant documentation
- Support investigation writing, root-causedocumentation, corrective actions, and closure of quality-system records
- Review and update preventive maintenance andcalibration documentation for accuracy, completeness, and alignment withcurrent practices
- Maintain trackers for open documents, investigations,CAPAs, calibration items, maintenance actions, and approval status
- Catalog computerized systems and online softwareplatforms used across the site
- Review, document, and update user access, securityroles, permissions, and system ownership
- Support periodic access reviews and removal ofinactive, duplicate, or inappropriate access
- Coordinate document routing, review, approval, andeffective-date activities within applicable electronic quality systems
- Support inspection-readiness anddocumentation-remediation initiatives
Requirements
Requirements
Required Qualifications
- 3-6+ years of GMP technical writing experience inpharmaceutical, biotech, or medical-device manufacturing
- Demonstrated experience authoring SOPs, WorkInstructions, deviations, investigations, and CAPAs
- Experience supporting calibration, maintenance,engineering, or equipment-related documentation
- Familiarity with electronic quality-management anddocument-control systems
- Strong understanding of GMP documentation, dataintegrity, version control, and approval workflows
- Ability to translate complex technical informationinto clear, compliant, and auditable documents
- Strong organizational skills and attention to detail