Deviation Writer

Job Description

Our client, a global pharmaceutical manufacturer, is seeking a Deviation Writer to join their expanding team. This individual will conduct investigations and processes. Responsibilities include performing historical searches, watching videos, interviewing colleagues, reviewing supporting documentation (batch records, technical assessments, SOPs, etc.), and housing this information in a proprietary system.

Responsibilities

• Conduct investigations specific to processes.
• Perform historical searches and watch videos related to aseptic production.
• Interview colleagues to gather information.
• Review supporting documentation such as batch records, technical assessments, and SOPs.
• Utilize and maintain information in a proprietary system daily.

Essential Skills

• Previous pharmaceutical experience in a GMP commercial setting.
• 2+ years of experience in Aseptic Manufacturing within a pharmaceutical environment.
• Experience conducting investigative processes, CAPA, and Root Cause Analysis.
• Systematic problem-solving skills with exposure to root cause analysis, investigative process, technical writing, or CAPA.
• Technical writing experience, including writing technical documents and CAPA reports.

Additional Skills & Qualifications

• Root Cause Analysis
• CAPA
• Technical Writing
• Process Improvement

Work Environment

This is a normal M-F, 1st shift opportunity. It is a cross-functional role within an office space and involves partnering with production on the floors