GMP Quality Technical Writer - CAPA & Investigations

Actalent; Irvine (CA); On-site; USD 45,000 - 65,000; Full time

Job summary

Actalent in Irvine, CA is seeking a Quality Technical Writer to support a quality and investigations team by drafting deviation reports, root cause analyses, and CAPA documentation within a regulated laboratory environment.

You will translate complex technical information into clear, compliant documentation, collaborate with quality assurance, investigations, and technical writing teams, and contribute to the burndown of open investigations while leveraging SAP documentation systems.

Qualifications

• Bachelor's degree in a scientific discipline.
• 35 years of experience in technical writing, preferably in a regulated environment.
• Proven experience writing deviation reports in a quality or GMP setting.
• Strong familiarity with CAPA processes and documentation.
• Hands-on experience using 5 Whys or Fishbone methodology for root cause analysis.
• Demonstrated ability to perform root cause analysis and document findings clearly and logically.
• Solid quality assurance and GMP knowledge.
• Experience with investigations and non-conformances in pharmaceutical or medical device environments.
• Excellent writing skills with the ability to produce precise, detailed, and compliant documentation.
• Experience working under FDA-regulated conditions.
• Ability to work autonomously, manage a demanding workload, and apply critical thinking to complex problems.

Responsibilities

• Write deviation reports detailing events, impacts, and corrective actions.
• Conduct root cause analyses using 5 Whys, Fishbone diagrams, or other structured approaches.
• Prepare detailed CAPA reports, ensuring accuracy, clarity, and alignment with quality and regulatory standards.
• Assist with corrective action investigations by gathering data, interviewing stakeholders, and organizing findings into formal reports.
• Obtain technical and process information from cross-functional team members and translate it into manuals, procedures, and other controlled documents.
• Write clear descriptions of processes, materials, and quality workflows to support GMP and quality assurance requirements.
• Support document redlining activities, ensuring revisions are correctly captured, tracked, and integrated into controlled documentation.
• Collaborate with quality assurance and technical writing teams, as well as other departments, to collect information and validate documentation.
• Interact with investigators and quality personnel to understand investigation details and ensure documentation is complete and accurate.
• Use critical thinking skills to work autonomously, identify gaps in information, and proactively seek out training and answers needed to complete investigations.
• Contribute to the burndown of a high volume of open investigations by producing timely, high-quality documentation.
• Leverage experience with SAP documentation systems, when applicable, to manage and maintain quality records.
• Utilize knowledge of QC lab investigations and microbiology, when applicable, to accurately document laboratory-related events and findings.

Skills

Technical writing

Regulated environment

Root cause analysis

Autonomous workstyle

Cross-functional collaboration

Quality Assurance

FDA-regulated

Education

Bachelor's degree in a scientific discipline

Tools

SAP documentation systems

Job description

Actalent in Irvine, CA is seeking a Quality Technical Writer to support a quality and investigations team by drafting deviation reports, root cause analyses, and CAPA documentation within a regulated laboratory environment.

You will translate complex technical information into clear, compliant documentation, collaborate with quality assurance, investigations, and technical writing teams, and contribute to the burndown of open investigations while leveraging SAP documentation systems.