Job Details
Posted 14 September, 2026
Job Id: 630493
QA Technical Writer
Job Description
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
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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, operate equipment |
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The max pay rate is $30-32/hr for this position
Equal Opportunity Employer
We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
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