QA Technical Writer (Pharma/Biotech/life science)

Job Description

Job Description

QA Technical Writer

Location: Memphis, TN 38118 — Onsite
Duration: 5+ Months, with possibility of extension
Work Hours: Monday–Friday, 8:00 AM–5:00 PM
Interview: Virtual

Job Id: CRLJP00002412

Pay rate: $32/hr on w2 all inclusive

Position Summary

We are seeking an experienced QA Technical Writer to support a cell and gene therapy manufacturing site in Memphis, TN. Reporting to the Manager, Compliance, this position will be responsible for creating, managing, reviewing, and maintaining high-quality technical and quality-system documentation within a regulated biotechnology/pharmaceutical environment.

The ideal candidate will have strong technical writing and documentation skills, excellent attention to detail, and the ability to translate complex scientific and manufacturing information into clear, concise, and compliant documentation. Experience working with deviations, CAPAs, change controls, SOPs, batch records, and other quality-system documents is highly preferred.

This is an excellent opportunity for a technical writer with biotechnology or pharmaceutical industry experience who enjoys collaborating with cross-functional teams and improving documentation processes in a highly regulated environment.

Key Responsibilities

• Generate and lead the facilitation and completion of quality-system documentation, including Deviations, CAPAs, Change Controls, and related records.
• Ensure documentation is clear, concise, accurate, complete, and compliant with company standards and applicable regulatory requirements.
• Complete routine and non-routine documentation assignments within established timelines and with general supervision.
• Work closely with internal stakeholders to gather information and ensure technical documentation accurately reflects processes, investigations, and outcomes.
• Facilitate document reviews and approvals while incorporating feedback from cross-functional teams and clients.
• Write, edit, and review technical documents, including SOPs, batch records, technical reports, and other manufacturing/quality documentation.
• Communicate findings, results, issues, and concerns effectively through both written and verbal communication.
• Develop and maintain strong working relationships with internal stakeholders and begin building effective relationships with clients.
• Identify opportunities to improve documentation processes, templates, and workflows to enhance clarity, efficiency, consistency, and compliance.
• Provide solutions to moderately complex documentation and compliance challenges.
• Lead or facilitate training sessions for internal teams and functional departments, as applicable.
• Perform other duties and responsibilities as assigned.

Required Qualifications

• 2–6 years of technical writing experience within the biotechnology or pharmaceutical industry.
• Experience working in a regulated GxP environment strongly preferred.
• Experience with quality-system documentation such as Deviations, CAPAs, and Change Controls preferred.
• 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 and present it in a clear, concise manner.
• Strong organizational, analytical, and project-management skills.
• Excellent verbal and written communication skills.
• Strong interpersonal skills with the ability to collaborate effectively across multiple functions.
• Proficiency with Microsoft Office Suite and document-management systems.

Education

• Associate’s degree or higher in Life Sciences, Biotechnology, Biochemistry, or a related scientific field preferred.

Physical Requirements

The successful candidate must be able to:

• Sit and/or walk for extended periods of time.
• Routinely lift, push, or pull up to 10 lbs. and occasionally up to 20 lbs.
• Stand, bend, and reach overhead occasionally.
• Move sufficiently between multiple office and facility locations.
• Use a keyboard and computer monitor and operate equipment requiring adequate visual acuity.

Ideal Candidate

The ideal candidate is a detail-oriented, critical thinker who can independently manage documentation assignments while working effectively with quality, manufacturing, technical, and cross-functional teams. Candidates who combine strong technical writing skills with hands-on experience in biotechnology, pharmaceuticals, quality systems, and regulated manufacturing environments are strongly encouraged to apply