Technical Writer

This posting is for an existing vacancy.

Job Title:

Technical Writer

Job Description

As a Technical Writer, you will be responsible for developing detailed and clear documentation for new processes, including step-by-step guides, standard operating procedures (SOPs), and quality control measures. You will assist in documenting and investigating nonconformances, creating reports that outline root cause analyses, corrective actions, and preventive measures. Writing concise and accurate summary reports for new processes and nonconformance investigations is essential.

Collaboration with various departments to gather necessary information and ensure documentation accuracy will be a key part of your role. Additionally, you will contribute to the continuous improvement of documentation practices and processes.

Responsibilities

+ Develop detailed and clear documentation for new processes, including SOPs and quality control measures.

+ Assist in documenting and investigating nonconformances, creating reports outlining root cause analysis, corrective actions, and preventive measures.

+ Write concise and accurate summary reports for new processes and investigations.

+ Collaborate with Operations Manager, quality control teams, and other departments to gather information and ensure documentation accuracy.

+ Contribute to continuous improvement of documentation practices and processes.

Essential Skills

+ At least 3 years of experience in document creation and technical writing.

+ Proficiency in utilizing office and ERP systems effectively.

+ Experience supporting investigations from a writing perspective.

+ Working knowledge in a FDA regulated environment.

+ Strong skills in document control, ERP systems, and Microsoft Office.

Additional

Skills & Qualifications

+ BS degree in Sciences with experience in writing CAPA investigations.

+ Ability to explain methodologies used to determine root causes.

+ Comfortable working in a sterile manufacturing contained area working with penicillin/cephalosporin). Cannot have any allergies to penicillin and be comfortable with showering after leaving the contained area.

+ 2-4 years of quality experience in technical writing, quality systems, and quality assurance.

+ Pharmaceutical quality experience preferred, though medical device or diagnostics experience is also valuable.

+ Basic understanding of quality systems and change controls.

Work Environment

The work environment is dynamic and fast-paced, reflecting the high standards and demands of the pharmaceuticals industry. You will be part of a team of approximately 200 dedicated professionals in the Operations department, focusing on collaboration and efficiency.

The role is onsite, from 8am to 5pm, with about 90% of the work conducted in an office setting and 10% in the lab duplex/contained area.

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 - $40.00/hr.

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)

Workplace Type

This is a fully onsite position in Irvine,CA.

Final date to receive applications

This position is anticipated to close on Mar 1, 2026.

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 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

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 due to a disability, please email actalentaccom (%20actalentaccom)  for other accommodation options.