Quality Technical Writer

Actalent; California (MO); Vor Ort; USD 55.000 - 69.000; Vollzeit

Benefits dieser Stelle

Medical, dental & vision

401(k) plan

Life Insurance

Short/Long-term disability

HSA

Transportation benefits

Employee Assistance Program

Paid time off

Zusammenfassung

Actalent is seeking a Quality Technical Writer for a 6-12 month contract in Irvine, CA. The role focuses on CAPA, OOS investigations, and root cause analysis, with onsite collaboration in a contained lab environment.

You will gather information from team members to write manuals and documentation, supporting deviations related to particulate matter and materials within the QA framework. A team of five investigators will collaborate on over 220 open investigations.

Qualifikationen

• Proficiency in technical writing.
• Experience with CAPA and quality assurance.
• Knowledge of GMP and investigations.
• Ability to handle non-conformances and CAPA investigations.
• Strong root cause analysis and writing.
• Experience in pharmaceutical or medical device industries.
• 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.
• Familiarity with 5 Whys or Fishbone methodology.
• FDA-related experience.

Aufgaben

• Conduct root cause analysis using methodologies such as 5 Whys or Fishbone.
• Write detailed descriptions on CAPA (corrective actions).
• Heavily engage 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.

Kenntnisse

Technical writing

CAPA & QA

GMP knowledge

Non-conformances & CAPA

Root cause analysis

Pharma/Medical device

Ausbildung

Bachelor's Degree in a scientific field

Jobbeschreibung

Job Description

Job Title: Quality Technical Writer

Job Description

We are seeking a skilled Quality Technical Writer to join our team. The ideal candidate will excel in technical report writing and will be working in a contained facility lab, focusing 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).
• Heavily engage 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.

Essential Skills

• 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.

Additional Skills & 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.

Work Environment

This position is a 6-12 month contract, with a minimum commitment through the end of the year. You will work within a cubicle closely with the QA department, collaborating with the quality department and a technical writing team of four other investigators. Interaction with other departments will be necessary. The role provides an opportunity to engage with over 220 open investigations

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.

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.

Application Deadline

This position is anticipated to close on Aug 14, 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 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.