Quality Technical Writer

Actalent; Irvine (CA); On-site; USD 55,000 - 69,000; Full time

Benefits offered by this job

Medical, dental & vision

401(k) Retirement Plan

Life Insurance

Disability

Health Spending Account

Transportation benefits

Employee Assistance Program

Paid Time Off

Job summary

Actalent is seeking a Quality Technical Writer to support quality and microbiology teams in Irvine, CA. The role centers on documenting investigations, deviations, and CAPA activities in a GMP/FDA-regulated environment.

You will collaborate with QC laboratories, microbiology, and QA teams to produce precise, compliant reports and procedures on timelines driven by quality and regulatory needs. This contract role emphasizes detailed scientific writing and cross-functional communication.

Qualifications

• Proven track record drafting investigation, deviation, non-conformance and OOS reports.
• Experience in GMP environments and FDA documentation expectations.
• Ability to translate complex technical information into user-friendly documentation.

Responsibilities

• Conduct particulate matter investigations with QC labs and microbiology teams.
• Perform root cause analysis using 5 Whys, Fishbone or similar tools.
• Draft clear CAPA deviation reports with data, analysis, conclusions.
• Assist with corrective action investigations and document findings.
• Translate technical input into manuals, reports and process descriptions.
• Describe processes related to deviations involving particulates and materials.

Skills

Technical writing

Root cause analysis

GMP knowledge

FDA documentation

Cross-functional collaboration

Quality systems

Education

Bachelor's degree in science

Tools

CAPA software

Job description

Job Title: Quality Technical Writer

Job Description

This role focuses on supporting quality and microbiology teams by conducting particulate matter investigations related to microbiology deviations and documenting findings through clear, detailed technical reports. The Quality Technical Writer works closely with QC laboratories and quality assurance teams in a contained facility, ensuring investigations, deviations, and corrective actions are accurately recorded and compliant with GMP and FDA expectations.

Responsibilities

• Conduct particulate matter investigations in collaboration with QC laboratories and microbiology teams, focusing on deviations related to microbiology and materials.
• Perform root cause analysis using methodologies such as 5 Whys, Fishbone diagrams, or other structured problem-solving tools to determine the underlying causes of non-conformances and deviations.
• Write clear, detailed CAPA (Corrective and Preventive Action) deviation reports, ensuring all relevant data, analysis, and conclusions are thoroughly documented.
• Assist with corrective action investigations by gathering information, organizing evidence, and documenting findings in a structured and compliant format.
• Obtain information from cross-functional team members and translate technical input into accurate, user-friendly documentation such as manuals, reports, and process descriptions.
• Draft detailed descriptions of processes and procedures related to deviations involving particulate matter and materials, ensuring alignment with quality and regulatory requirements.
• Document non-conformances, out-of-specification (OOS) investigations, and deviation reports in accordance with GMP and internal quality standards.
• Collaborate closely with microbiology, quality assurance, and technical writing teams to ensure consistency, clarity, and completeness of all investigation-related documentation.
• Work interdependently with other departments to gather data, clarify issues, and ensure timely completion of investigations and CAPA documentation.
• Maintain high standards of written communication, ensuring all reports are precise, logically structured, and suitable for internal review and regulatory scrutiny.

Essential Skills

• Strong technical writing skills with proven experience drafting detailed investigation reports, deviation reports, non-conformance reports, and OOS investigations.
• Experience working in a laboratory or GMP environment, with 35 years of industry experience in a scientific or quality-focused setting.
• Hands-on experience with CAPA processes, including documenting corrective and preventive actions for quality investigations.
• Proficiency in root cause analysis techniques such as 5 Whys and Fishbone (Ishikawa) methodologies.
• Knowledge of GMP (Good Manufacturing Practice) principles and their application in pharmaceutical or medical device environments.
• Experience conducting or supporting investigations related to non-conformances, deviations, and OOS results.
• Familiarity with FDA-regulated environments and expectations for documentation and quality investigations.
• Bachelors degree in a scientific discipline or a closely related field.
• Ability to collaborate effectively with laboratory, microbiology, quality assurance, and cross-functional teams to gather and interpret technical information.
• Strong attention to detail and ability to produce accurate, clear, and compliant documentation under timelines driven by quality and regulatory needs.

Additional Skills & Qualifications

• Experience in the pharmaceutical industry is preferred, with openness to candidates from medical device environments.
• Prior involvement in CAPA investigations and non-conformance management is highly beneficial.
• Exposure to FDA audits or inspections and familiarity with documentation expectations in such contexts.
• Ability to translate complex scientific or technical concepts into clear written documentation for diverse internal stakeholders.
• Comfort working on multiple open investigations simultaneously while maintaining organization and prioritization.
• Demonstrated ability to work within structured quality systems and follow established procedures and templates.
• Experience collaborating with technical writing teams or investigation teams in a quality or QA department.

Work Environment

This is a 612 month contract role with the potential for extension in six-month increments, supported by a high volume of open investigations. The position is based in a contained facility environment and involves close collaboration with the microbiology team within the quality assurance department. The Quality Technical Writer works primarily at a cubicle workstation alongside the quality department and a technical writing team that includes other investigators. The role requires frequent interaction with multiple departments, fostering a collaborative and interdependent work culture focused on quality, compliance, and continuous improvement.

Job Type & Location

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

Pay And Benefits

The pay range for this position is $40.00 - $50.00/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)

Job Type & Location

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

Application Deadline

This position is anticipated to close on Nov 18, 2026.

Workplace Type

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 [e-mail] 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.