GMP Analytical Documentation Specialist (Hybrid)

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

Job summary

Experic, LLC is seeking a Technical Writer, Analytical to support QMS documentation for the laboratory and Analytical functions. You will draft, revise, and maintain compliant GMP documentation and serve as a liaison between Analytical R&D and Quality Assurance to ensure regulatory alignment.

The role requires strong technical writing, scientific comprehension, and familiarity with GMP lab documentation in a regulated pharmaceutical/CDMO environment.

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

• Draft, revise, format, and coordinate controlled laboratory documentation including SOPs, test methods, specifications, analytical procedures, forms, protocols, worksheets.
• Coordinate document review and approval workflows between Analytical R&D and QA.
• Support document control activities within the electronic QMS/document management system.
• Assist with deviations, investigations, CAPA, and change control documentation.
• Partner with laboratory personnel to ensure procedures reflect current analytical practices and regulatory requirements.
• Support data integrity and GDP compliance initiatives within laboratory documentation practices.
• Assist with maintaining inspection-ready documentation and audit preparedness.
• Coordinate document revisions, periodic reviews, archival activities, and implementation of updated procedures.
• Support onboarding and training documentation activities related to laboratory procedures.

Skills

Technical writing

Scientific writing

GMP compliance

Project management

Cross-functional teamwork

Microsoft Office

QMS/document management

Education

Bachelor’s degree in Chemistry, Biology, Pharmaceutical Sciences, Life Sciences, Technical Writing, or related discipline

Tools

Electronic document management system (EDMS)

Job description

Experic, LLC is seeking a Technical Writer, Analytical to support QMS documentation for the laboratory and Analytical functions. You will draft, revise, and maintain compliant GMP documentation and serve as a liaison between Analytical R&D and Quality Assurance to ensure regulatory alignment.

The role requires strong technical writing, scientific comprehension, and familiarity with GMP lab documentation in a regulated pharmaceutical/CDMO environment.