Quality Technical Writer: CAPA & QA Investigations

Actalent; California (MO); On-site; USD 55,000 - 69,000; Full time

Benefits offered by this job

Medical, dental & vision

401(k) plan

Life Insurance

Short/Long-term disability

HSA

Transportation benefits

Employee Assistance Program

Paid time off

Job summary

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.

Qualifications

• 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.

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.

Skills

Technical writing

CAPA & QA

GMP knowledge

Non-conformances & CAPA

Root cause analysis

Pharma/Medical device

Education

Bachelor's Degree in a scientific field

Job description

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.