GMP Technical Writer for Pharmaceutical Documentation

ClinLab Solutions Group; North Brunswick Township (NJ); On-site; USD 70,000 - 90,000; Full time

Job summary

A leading pharmaceutical firm in North Brunswick Township is seeking a Technical Writer to manage GMP documentation and ensure compliance with FDA and regulatory requirements. The ideal candidate will have a Bachelor's degree in a related field and 2-5 years of technical writing experience in a regulated environment. Responsibilities include authoring Master Batch Records and collaborating with cross-functional teams to enhance document quality. This full-time role offers growth opportunities in a dynamic industry.

Qualifications

• Bachelor's degree preferred in a related field such as Pharmaceutical Sciences, Chemistry, or Engineering.
• 2-5 years of technical writing experience in a GMP-regulated environment.
• Hands-on experience with batch record preparation and review is strongly preferred.

Responsibilities

• Author and maintain Master Batch Records and Executed Batch Records for manufacturing.
• Collaborate with SMEs to create clear and compliant documentation.
• Review batch records for compliance with cGMP and internal standards.

Skills

Excellent written and verbal communication skills

Attention to detail

Proficiency in Microsoft Word

Proficiency in Microsoft Excel

Proficiency in Microsoft PowerPoint

Experience with document control systems

Education

Bachelor’s degree in Pharmaceutical Sciences or related field

Equivalent experience in a regulated environment

Tools

Dot Compliance

MasterControl

Veeva

Job description

A leading pharmaceutical firm in North Brunswick Township is seeking a Technical Writer to manage GMP documentation and ensure compliance with FDA and regulatory requirements. The ideal candidate will have a Bachelor's degree in a related field and 2-5 years of technical writing experience in a regulated environment. Responsibilities include authoring Master Batch Records and collaborating with cross-functional teams to enhance document quality. This full-time role offers growth opportunities in a dynamic industry.