GMP Analytical Documentation Specialist

Experic LLC; Cranbury Township (NJ); Hybrid; USD 100,000 - 130,000; Full time

Job summary

Prismhr Hire in Cranbury, NJ is seeking a Technical Writer, Analytical to support QMS documentation for the laboratory and Analytical functions. The role partners with Analytical R&D and QA to draft, revise, route, and maintain compliant GMP laboratory documentation for testing and development activities.

You will coordinate document review workflows, assist with deviations and CAPA, support data integrity and GDP compliance, and help ensure inspection-ready documentation and audit preparedness

Qualifications

• Bachelor’s degree preferred in Chemistry, Biology, Pharmaceutical Sciences, Life Sciences, Technical Writing, or related discipline.
• Minimum 2–5 years of experience in pharmaceutical, biotechnology, medical device, or other regulated GMP laboratory environments.
• Experience authoring and/or coordinating GMP laboratory documentation required.
• Familiarity with analytical laboratory operations and documentation practices preferred.
• Experience with Quality Management Systems (QMS) and electronic document management systems preferred.
• Working knowledge of cGMP, GDP, FDA regulations, and data integrity expectations required.

Responsibilities

• Drafts, revises, formats, and coordinates-controlled laboratory documentation including SOPs, test methods, specifications, analytical procedures, forms, protocols, worksheets, and validation documentation.
• Coordinates document review and approval workflows between Analytical R&D and QA.
• Supports document control activities within the electronic QMS/document management system.
• Assists with laboratory-related deviations, investigations, CAPA, and change control documentation.
• Partners with laboratory personnel to ensure procedures accurately reflect current analytical practices and regulatory requirements.
• Supports data integrity and GDP compliance initiatives within laboratory documentation practices.
• Assists with maintaining inspection-ready documentation and audit preparedness.
• Coordinates document revisions, periodic reviews, archival activities, and implementation of updated procedures.
• Supports onboarding and training documentation activities related to laboratory procedures.

Skills

Technical writing

Scientific writing

Project management

Collaboration

Education

Bachelor’s degree

Tools

Microsoft Office

Document management systems

Job description

Prismhr Hire in Cranbury, NJ is seeking a Technical Writer, Analytical to support QMS documentation for the laboratory and Analytical functions. The role partners with Analytical R&D and QA to draft, revise, route, and maintain compliant GMP laboratory documentation for testing and development activities.

You will coordinate document review workflows, assist with deviations and CAPA, support data integrity and GDP compliance, and help ensure inspection-ready documentation and audit preparedness