QA Technical Writer

Job Description

Job 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.

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 Product 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 Experience:

• 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.

Knowledge, Skills, and Abilities:

• 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.