QA Technical Writer

Job Title: QA Technical WriterDuration: 04+MonthsSalary: $32.00-$33.00/hr on W2 .Location: Memphis, Tennessee 38118, USAInterview will be virtualMon-Fri 8am-5pmPOSITION 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 guidelinesComplete routine and some non-routine documentation assignments within prescribed timeline under general supervisionWork closely with stakeholders to gather information and ensure accuracy and completeness of documentationFacilitate document reviews and approvals, incorporating feedback from cross-functional teams and clientsCollaborate in writing and editing technical documents including standard operating procedures (SOPs), batch records, technical reports, etcCommunicate results and/or concerns verbally and in writingDevelop and maintain relationships with internal stakeholders as well as begin building relationships with clientsProvides solutions of moderate to complex scope to continuously improve documentation processes and templates to enhance clarity, efficiency, and complianceLeads in performing trainings for internal team and functional departments as applicablePerform other duties as assignedEDUCATION AND/OR WORK EXPERIENCE REQUIREMENTS:Associate’s degree or higher in Life Sciences, Biotechnology, Biochemistry, or related field preferredMinimum of 2-6 years of technical writing experience in the biotechnology or pharmaceutical industry, preferably in cell and gene therapyExceptional writing, editing, and proofreading skills with attention to detailAbility to interpret and present complex scientific data in a clear and concise mannerProficient in Microsoft Office Suite and document management systemsStrong organizational and project management skillsExcellent communication and interpersonal skills