Quality Technical Writer

About the role

We are seeking a skilled Quality Technical Writer to join our team in a 6-12 month contract role based in Irvine, CA. This fully onsite position involves working closely with the QA department and a technical writing team of four other investigators, collaborating on over 220 open investigations within a contained facility lab. The role focuses on CAPA, OOS lab investigations, and root cause analysis.

Responsibilities

• Conduct root cause analysis using methodologies such as 5 Whys or Fishbone.
• Write detailed descriptions on CAPA (corrective actions).
• Engage heavily in CAPA deviation report writing and assist with corrective action investigations.
• Gather information from team members and write manuals and other documentation.
• Document processes regarding deviations related to particulate matter and materials.

Requirements

• Proficiency in technical writing.
• Experience with CAPA and quality assurance.
• Knowledge of GMP and investigations.
• Ability to handle non-conformances and CAPA investigations.
• Strong skills in root cause analysis and writing.
• Experience in pharmaceutical or medical device industries.

Qualifications

• Bachelor's Degree in a scientific field.
• 3-5 years of industry experience in a lab or GMP environment.
• Experience writing deviation reports, NCs, and OOS investigations.
• Experience with CAPA is a plus.
• Familiarity with 5 Whys or Fishbone methodology.
• FDA-related experience.

Pay

The pay range for this position is $40.00 - $50.00 per hour.

Benefits

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. If eligible, benefits for this temporary role may include:

• Medical, dental, and vision insurance.
• Critical Illness, Accident, and Hospital coverage.
• 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).

Schedule

This is a contract position with a minimum commitment through the end of the year, anticipated to close on August 14, 2026.