GMP QMS Documentation Lead – Technical Writer

Experic; Cranbury Township (NJ); On-site; USD 80,000 - 110,000; Full time

Job summary

Experic in Cranbury, NJ is seeking a Technical Writer to lead QMS documentation within Operations, drafting, revising, and routing controlled GMP documents and ensuring inspection readiness.

You will collaborate with Manufacturing, Packaging, QA and Facilities to reflect current practices, maintain document control in the electronic QMS, and support audits and continuous improvement initiatives.

Qualifications

• Bachelor's degree preferred in Life Sciences, Engineering, Technical Writing, or related field; equivalent experience may be considered.
• 3+ years of experience in a pharmaceutical, biotechnology, medical device, or other regulated GMP environment.
• Experience leading GMP investigation, including Root Cause Analysis methodologies, required.
• Experience authoring and/or coordinating GMP documentation required.

Responsibilities

• Leads deviation and complaint Root Cause Analysis and CAPA development for GMP investigations.
• Leads change control documentation activities related to Operations.
• Drafts, revises, formats, and coordinates controlled GMP documentation including SOPs, batch records, forms, work instructions, logbooks, and protocols.
• Coordinates document review, approval, and implementation activities between Operations and QA.
• Supports document periodic reviews, revisions, obsolescence activities, and version control.

Skills

Technical writing

Document control

GMP compliance

Cross-functional collaboration

Microsoft Office

Education

Bachelor's degree in Life Sciences or related

Tools

QMS software

Electronic document management system

Job description

Experic in Cranbury, NJ is seeking a Technical Writer to lead QMS documentation within Operations, drafting, revising, and routing controlled GMP documents and ensuring inspection readiness.

You will collaborate with Manufacturing, Packaging, QA and Facilities to reflect current practices, maintain document control in the electronic QMS, and support audits and continuous improvement initiatives.