Quality Technical Writer

Job Title: Quality Technical Writer

Job Description

The Quality Technical Writer supports a quality and investigations team by primarily drafting detailed deviation reports, root cause analyses, and CAPA documentation within a highly regulated laboratory environment. This role focuses on translating complex technical and scientific information into clear, compliant documentation that supports quality assurance, investigations, and continuous improvement activities.

Responsibilities

• Write comprehensive deviation reports that clearly describe events, impacts, and corrective and preventive actions.
• Conduct and document root cause analysis using methodologies such as 5 Whys, Fishbone diagrams, or other structured approaches.
• Prepare detailed CAPA (Corrective and Preventive Action) 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.

Essential Skills

• Bachelors 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 (Good Manufacturing Practice) 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.

Additional Skills & Qualifications

• Experience documenting in SAP systems.
• Experience writing QC lab investigations.
• Microbiology experience or exposure to microbiology-related investigations.
• Pharmaceutical industry experience preferred; medical device experience is also valued.
• Prior experience with CAPA investigations and non-conformance documentation.
• Experience in technical writing within quality assurance or laboratory environments.
• Ability to collaborate effectively with cross-functional teams, including quality, investigations, and technical writing groups.
• Comfort working on a contract basis (612 months) with potential for extension or direct hire based on business needs.
• Openness to returning as a former employee or consultant, where applicable.

Work Environment

The role is based in a contained facility laboratory and office setting within the quality assurance department, working closely with a dedicated burndown team and a group of investigators and technical writers. The position is demanding and fast-paced, with over 100 open investigations, requiring the ability to work independently, manage multiple priorities, and maintain composure under stress. The contract duration is typically 612 months, with extensions driven by business needs, and many investigators have been extended beyond 12 months or converted to direct hire. The work involves regular interaction with various departments, frequent collaboration with quality and technical writing teams, and the use of systems such as SAP for documentation. The environment emphasizes autonomy, initiative, problem-solving, and continuous learning, with expectations that the individual will proactively seek training and information to complete investigations and documentation accurately.

This is a Contract position based out of Irvine, CA.

The pay range for this position is $40.00 - $40.00/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long-term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time Off/Leave (PTO, Vacation or Sick Leave)

This is a Contract position based out of Irvine, CA.

This position is anticipated to close on Oct 30, 2026.

This is a fully onsite position in Irvine,CA.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.