QA 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

Reporting to the Manager Compliance, the Compliance Specialist is responsible for creating, managing, and maintaining technical documentation for our cell and gene therapy manufacturing site. This includes writing, editing, and reviewing documents such as quality systems (deviations, change controls and capas). The ideal candidate will be a critical thinker with experience in biotechnology or pharmaceuticals, excellent writing skills, and ready to apply specialized skills in technical writing, compliance, data analysis…etc..in a regulated environment.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Generate and leading the facilitation in the completion of quality system documents for the manufacturing site (Deviations, CAPAs, Change Controls, etc)
• Ensure all documentation is clear, concise, and adheres to company standards and regulatory guidelines
• Complete routine and some non-routine documentation assignments within prescribed timeline under general supervision
• Work closely with stakeholders to gather information and ensure accuracy and completeness of documentation
• Facilitate document reviews and approvals, incorporating feedback from cross-functional teams and clients
• Collaborate in writing and editing technical documents including standard operating procedures (SOPs), batch records, technical reports, etc
• Communicate results and/or concerns verbally and in writing
• Develop and maintain relationships with internal stakeholders as well as begin building relationships with clients
• Provides solutions of moderate to complex scope to continuously improve documentation processes and templates to enhance clarity, efficiency, and compliance
• Leads in performing trainings for internal team and functional departments as applicable
• Perform other duties as assigned

EDUCATION AND/OR WORK EXPERIENCE REQUIREMENTS:

• Associate’s degree or higher in Life Sciences, Biotechnology, Biochemistry, or related field preferred
• Minimum of 2-6 years of technical writing experience in the biotechnology or pharmaceutical industry, preferably in cell and gene therapy
• Exceptional writing, editing, and proofreading skills with attention to detail
• Ability to interpret and present complex scientific data in a clear and concise manner
• Proficient in Microsoft Office Suite and document management systems
• Strong organizational and project management skills
• Excellent communication and interpersonal skills