Job Description
We are seeking a Senior Technical Writer to support QC and analytical investigations for a cell therapy manufacturing program preparing for clinical and commercial scale up. This role will focus on authoring high quality, inspection ready investigation documentation related to analytical testing in a fast paced, regulated environment with minimal ramp up time.
The ideal candidate brings strong GMP investigation writing experience, a solid understanding of QC and analytical laboratory operations, and the ability to translate complex analytical data and technical inputs into clear, compliant documentation without extensive training or oversight.
This is a highly execution focused role supporting a time sensitive QC and release testing program.
Key Responsibilities
Investigation Documentation & Writing
• Author, revise, and finalize QC and analytical investigation reports, including deviations, OOS/OOT investigations, impact assessments, and related documentation
• Translate inputs from QC, Quality, Analytical Development, and Manufacturing into clear, defensible investigation narratives
• Ensure all documentation meets GMP, regulatory, and data integrity standards
• Maintain consistency, clarity, and compliance across investigations in a high volume environment
QC & Analytical Support
• Support investigations related primarily to QC and analytical testing deviations, with potential exposure to manufacturing and process investigations
• Understand analytical workflows well enough to accurately reflect testing events, timelines, data interpretation, and technical context in documentation
• Partner closely with QC and Quality teams to gather information efficiently and meet aggressive timelines
Execution & Speed
• Manage multiple investigations concurrently while maintaining quality and attention to detail
• Prioritize work based on QC release, testing, and batch disposition timelines
• Adapt quickly to evolving methods, templates, systems, and analytical processes
We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.
Required Skills & Experience
• 7–10+ years of experience in GMP regulated pharmaceutical or biotech QC or analytical environments
• Demonstrated experience writing investigations (QC deviations, OOS/OOT, CAPAs, impact assessments)
• Experience with structured investigation and root cause analysis tools (e.g., Fishbone/Ishikawa diagrams, 5 Whys)
• Strong working knowledge of GMP documentation practices and regulatory expectations
• Ability to step into an investigation workflow with minimal training or hand holding
• Experience supporting cell therapy, gene therapy, or biologics programs
• Experience working in fast paced QC or laboratory environments with tight turnaround times
• Strong written communication skills — able to clearly articulate complex analytical and technical issues
Nice to Have Skills & Experience
• Prior experience supporting QC and analytical investigations for cell therapy programs
• Prior hands on or investigation support experience with analytical techniques such as flow cytometry, automated cell counters, PCR, ELISA, and other standard QC laboratory methods
• Familiarity with LIMS, electronic laboratory notebooks (ELN), and quality management systems
• Experience supporting QC investigations at CMOs or external testing laboratories
• Background in both analytical/QC focused and manufacturing investigations
Benefit packages for this role will start on the 1st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.