QA Technical Writer; Pharma​/Biotech​/life science) in Memphis

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

Pay rate: $32/hr on w2 all inclusive

We are seeking an experienced QA Technical Writerto 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 document sis highly .

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.

• 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, includingSOPs, 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.

• 2–6 years of technical writing experience within the biotechnology or pharmaceutical industry.
• Experience working in aregulated GxP environment strongly .
• Experience with quality-system documentation such as Deviations, CAPAs, and Change Controls.
• Experience incell and gene therapyor 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 Suiteand document-management systems.

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

The successful candidate must be able to:

• Sit and/or walk for extended periods of time.
• Routinely lift, push, or pull up to10 lbs.and occasionally up to20 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.

The ideal candidate is adetail-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