QA Investigator / Technical Writer

Job Title : Investigation and Deviation Writer

Job Description

We are seeking a dedicated Investigation and Deviation Writer responsible for writing and completing investigations and deviations from a compliance and operations perspective. This role involves conducting root cause analyses and managing the full lifecycle of investigations, from initiation to closure, to ensure manufacturing and GMP compliance.

Responsibilities

• Determine the causes and preventative actions of Deviations, Non-Conformances, Out-of-Specification (OOS), Out-of-Trend (OOT), field complaints, and environmental excursion investigations.
• Drive investigations to uncover true root causes using appropriate tools and benchmark industry standards.
• Define and implement effective preventative actions to prevent recurrence.
• Manage multiple investigations in different stages to efficiently meet compliance deadlines and product release dates.
• Collaborate with cross-functional teams to develop and track Corrective and Preventative Action (CAPA) plans.
• Identify and create appropriate trending rules that trigger corrective actions.
• Analyze process data and evaluate trends to identify major improvement opportunities.
• Utilize change management approaches effectively.
• Develop training materials to educate personnel on writing problem statements and using root cause analysis tools.
• Champion CAPA plans and implementation.
• Provide ongoing communication plans for deviations and CAPAs.
• Oversee timely completion of deviations, CAPAs, and Change Controls.
• Ensure adherence to quality standards.

Essential Skills

Additional Skills & Qualifications

Work Environment

Job Type & Location

This is a Contract to Hire position based out of Allendale, NJ.

Pay and Benefits

The pay range for this position is $40.00 - $45.00 / 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 :

Workplace Type

This is a fully onsite position in Allendale,NJ.

Application Deadline

This position is anticipated to close on Nov 27, 2025.