QA Technical Writer

About the role

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, and data analysis in a regulated environment.

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 timelines 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
• Provide solutions of moderate to complex scope to continuously improve documentation processes and templates to enhance clarity, efficiency, and compliance
• Lead in performing trainings for internal team and functional departments as applicable
• Perform other duties as assigned

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

Physical Requirements

• Must be able to sit/walk for long periods of time
• Must be able to lift, push, pull to 10 lbs. routinely; 20 lbs. occasionally
• Must be able to work standing, bending, and reaching overhead occasionally
• Must be able to move sufficiently between multiple office and facility locations
• Must have visual acuity to use a keyboard, computer monitor, and operate equipment

Pay

The maximum pay rate for this position is $30–$32 per hour.