GMP Technical Writer & QMS Liaison

Experic, LLC; New Jersey; On-site; USD 80,000 - 110,000; Full time

Job summary

Experic, LLC, located in Cranbury, NJ, is seeking a Technical Writer – Operations to lead Quality Management System (QMS) documentation activities. This role requires strong technical writing skills and collaboration with cross-functional teams in Manufacturing, Packaging, Warehouse, and Quality Assurance.

The ideal candidate will have over 3 years of experience in a GMP environment and be familiar with regulatory documentation practices. The position offers a full-time classification and is based in the Cranbury office.

Qualifications

• 3+ years of experience in a pharmaceutical, biotechnology, medical device, or regulated GMP environment.
• Experience leading GMP investigation, including Root Cause Analysis methodologies.
• Familiarity with cGMP requirements and FDA regulatory expectations required.

Responsibilities

• Leads deviation and complaint Root Cause Analysis and CAPA development.
• Drafts, revises, formats, and coordinates controlled GMP documentation.
• Coordinates document review and approval activities between Operations and QA.

Skills

Technical writing and document formatting skills

Attention to detail

Organizational skills

Collaboration and communication skills

Knowledge of GMP documentation standards

Proficiency in Microsoft Office

Education

Bachelor’s degree in Life Sciences, Engineering, Technical Writing, or related field

Tools

Quality Management Systems (QMS)

Document control systems

Microsoft Office

Job description

Experic, LLC, located in Cranbury, NJ, is seeking a Technical Writer – Operations to lead Quality Management System (QMS) documentation activities. This role requires strong technical writing skills and collaboration with cross-functional teams in Manufacturing, Packaging, Warehouse, and Quality Assurance.

The ideal candidate will have over 3 years of experience in a GMP environment and be familiar with regulatory documentation practices. The position offers a full-time classification and is based in the Cranbury office.