QA Technical Writer – Biopharma GMP Documentation Lead

Energy Jobline ZR; Memphis (TN); On-site; USD 39,000 - 50,000; Full time

Job summary

Energy Jobline ZR is seeking an experienced QA Technical Writer to support a cell and gene therapy manufacturing site in Memphis, TN. The role focuses on creating, reviewing, and maintaining high-quality technical and quality-system documentation within a regulated biotech/pharma environment.

The ideal candidate will translate complex scientific and manufacturing information into compliant documentation, working with deviations, CAPAs, change controls, SOPs, batch records, and other

Qualifications

• 2–6 years of technical writing experience within the biotechnology or pharmaceutical industry.
• Experience in a regulated GxP environment.
• Experience with quality-system documentation such as Deviations, CAPAs, and Change Controls.
• Experience in cell and gene therapy or other advanced biomanufacturing environments is highly desirable.
• Exceptional technical writing, editing, proofreading, and documentation skills.
• Strong attention to detail and commitment to documentation accuracy.
• Ability to interpret complex scientific and technical information.
• Strong organizational, analytical, and project-management skills.
• Excellent verbal and written communication skills.
• Strong interpersonal skills with cross-functional collaboration.

Responsibilities

• Generate and lead the completion of quality-system documentation (Deviations, CAPAs, Change Controls).
• Ensure docs are clear, accurate, and compliant with regulatory requirements.
• Complete routine and non-routine documentation tasks within timelines.
• Collaborate with internal stakeholders to capture process information and outcomes.
• Facilitate document reviews and approvals with cross-functional input.
• Write, edit, and review SOPs, batch records, technical reports, and related docs.
• Communicate findings and issues clearly in written and verbal form.
• Build relationships with internal teams and clients over time.
• Identify opportunities to improve documentation templates and workflows.
• Provide solutions to moderately complex documentation and compliance challenges.
• Lead or facilitate training sessions as applicable.

Skills

Technical writing

GxP knowledge

Editing & proofreading

Documentation management

Cross-functional collaboration

Education

Associate’s degree or higher in Life Sciences, Biotechnology, Biochemistry, or related field

Tools

Microsoft Office Suite

Document management systems

Job description

Energy Jobline ZR is seeking an experienced QA Technical Writer to support a cell and gene therapy manufacturing site in Memphis, TN. The role focuses on creating, reviewing, and maintaining high-quality technical and quality-system documentation within a regulated biotech/pharma environment.

The ideal candidate will translate complex scientific and manufacturing information into compliant documentation, working with deviations, CAPAs, change controls, SOPs, batch records, and other