Technical Writer - Pharma

HonorVet Technologies; Memphis (TN); On-site; USD 65,000 - 90,000; Full time

Job summary

HonorVet Technologies in Memphis, TN is seeking a QA Technical Writer to create, edit, and maintain technical documentation for cell and gene therapy manufacturing. Reporting to the Manager Compliance, you will tackle deviations, CAPAs, change controls, SOPs, batch records, and technical reports within a regulated life sciences environment.

The ideal candidate has 2–6 years of biotech/pharma writing experience, strong editing skills, and proficiency with Microsoft Office and document management

Qualifications

• Associate's degree or higher in Life Sciences, Biotechnology, Biochemistry, or related field preferred.
• 2–6 years of technical writing experience in biotechnology or pharmaceutical industries, preferably cell and gene therapy.
• Exceptional writing, editing, and proofreading skills with attention to detail.
• Ability to interpret and present complex scientific data clearly and concisely.
• Proficient in Microsoft Office Suite and document management systems.
• Strong organizational and project management skills.
• Excellent communication and interpersonal skills.

Responsibilities

• Generate and lead 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

Skills

Technical writing

Editing

Documentation management

Biopharma knowledge

SOP writing

Communication

Education

Life Sciences degree

Tools

Microsoft Office

Document management systems

Job description

HonorVet Technologies (SDVOSB) provides specialized and scalable staffing solutions to pharmaceutical companies, medical device companies, biotech organizations, CROs, research laboratories, and life sciences organizations across the United States. With strong delivery capabilities and rapid turnaround times, we support contract, direct hire, project-based, and consulting staffing needs across clinical research, pharmacovigilance, regulatory affairs, quality assurance, quality control, medical affairs, manufacturing, validation, and scientific operations. Our dedicated recruitment team focuses on delivering qualified life sciences and pharmaceutical professionals efficiently while ensuring quality, compliance, and client satisfaction.

Job Title: QA Technical Writer

Job Location: Memphis, TN
Job Duration: 05 Months
Shift: Mon-Fri 8am-5pm

POSITION SUMMARY

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