Job Opportunity in Memphis, TN: QA Technical Writer
Join our dynamic team in Memphis, TN, where you will play a crucial role in advancing cell and gene therapy manufacturing. As a QA Technical Writer, you will be responsible for creating, managing, and maintaining essential technical documentation, ensuring compliance with regulatory standards. This is a fantastic opportunity for a critical thinker with a passion for biotechnology or pharmaceuticals to contribute to a cutting-edge field.
Key Responsibilities:
Lead the creation and facilitation of quality system documents for our manufacturing site, including Deviations, CAPAs, and Change Controls.
Ensure all documentation is clear, concise, and adheres to company standards and regulatory guidelines.
Complete routine and some non-routine documentation assignments within prescribed timelines.
Collaborate with stakeholders to gather information, ensuring accuracy and completeness of documentation.
Facilitate document reviews and approvals, incorporating feedback from cross-functional teams and clients.
Write and edit technical documents including SOPs, batch records, and technical reports.
Communicate results and/or concerns verbally and in writing.
Develop and maintain relationships with internal stakeholders and clients.
Provide solutions to improve documentation processes and templates for clarity, efficiency, and compliance.
Lead training sessions for internal teams and functional departments.
Requirements:
Associate's degree or higher in Life Sciences, Biotechnology, Biochemistry, or related field.
Minimum of 2-6 years of technical writing experience in the biotechnology or pharmaceutical industry.
Exceptional writing, editing, and proofreading skills with attention to detail.
Proficient in Microsoft Office Suite and document management systems.
Strong organizational and project management skills.
Excellent communication and interpersonal skills.
Preferences:
Experience in cell and gene therapy.
Ability to interpret and present complex scientific data in a clear and concise manner.
Ready to make an impact in the field of biotechnology? Apply now and become a part of our innovative team in Memphis, TN!
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Numbers & Facts
Location
Memphis, TN
Skills
Biochemistryunmatched
Biologyunmatched
Biotech and Pharmaceuticalunmatched
Change Controlunmatched
Communication Skillsunmatched
Cross-Functionalunmatched
Detail Orientedunmatched
Document Managementunmatched
Documentationunmatched
Documentation Reviewunmatched
Editingunmatched
Gene Therapyunmatched
Interpersonal Skillsunmatched
Maintain Complianceunmatched
Manufacturingunmatched
Manufacturing Systemsunmatched
Microsoft Officeunmatched
Organizational Skillsunmatched
Presentation/Verbal Skillsunmatched
Process Improvementunmatched
Project/Program Managementunmatched
Proofreadingunmatched
Quality Assuranceunmatched
Regulationsunmatched
Regulatory Complianceunmatched
Standard Operating Procedures (SOP)unmatched
Technical Editingunmatched
Technical Writingunmatched
Writing Skillsunmatched
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