Biotech QA & Compliance Technical Writer

RADgov Inc.; Memphis (TN); On-site; USD 65,000 - 90,000; Full time

Job summary

RADgov Inc. in Memphis, TN seeks a Compliance Specialist to create, edit and maintain technical documentation for our cell and gene therapy manufacturing site, ensuring compliance with quality systems and regulatory guidelines.

The role requires strong writing and editing skills, collaboration with cross-functional teams, and training responsibilities. Prior biotech/pharma writing experience is preferred.

Qualifications

• Strong writing, editing and proofreading skills with attention to detail
• Ability to interpret and present complex scientific data clearly
• Proficient in Microsoft Office Suite and document management systems
• Excellent communication and interpersonal skills
• Strong organizational and project management abilities

Responsibilities

• Generate and lead the completion of quality system documents (deviations, CAPAs, change controls)
• Ensure documentation adheres to company standards and regulatory guidelines
• Complete routine and some non-routine documentation within prescribed timelines
• Collaborate with stakeholders to gather information and ensure accuracy
• Facilitate document reviews and approvals with cross-functional teams
• Contribute to writing/editing SOPs, batch records, and technical reports
• Communicate results and concerns clearly in writing and verbally
• Develop relationships with internal stakeholders and clients
• Propose improvements to documentation processes and templates
• Lead trainings for internal teams as applicable
• Perform other duties as assigned

Skills

Writing

Editing

Proofreading

Communication

Interpersonal skills

Project management

Education

Associate's degree or higher in Life Sciences

Job description

RADgov Inc. in Memphis, TN seeks a Compliance Specialist to create, edit and maintain technical documentation for our cell and gene therapy manufacturing site, ensuring compliance with quality systems and regulatory guidelines.

The role requires strong writing and editing skills, collaboration with cross-functional teams, and training responsibilities. Prior biotech/pharma writing experience is preferred.