Technical Writer — GMP Investigations Leader

Johnson & Johnson Co.; Hopewell Township (NJ); On-site; USD 79,000 - 128,000; Full time

Job summary

Johnson & Johnson in Titusville, NJ seeks a Technical Writer to lead GMP documentation and investigations in the NJ Stability Lab Operations. This role requires technical writing, problem solving, and strong attention to detail.

You will author SOPs, validation protocols, and reports from conception to utilization, review data, provide guidance to investigators, and support Health Authority inspections with clear, compliant documentation.

Qualifications

• Knowledge of analytical technologies used in QC laboratories (HPLC, dissolution, IR, Karl Fischer).
• Experience in a QC laboratory as a bench analyst.
• Strong written, verbal, and interpersonal communication with attention to detail.
• Understanding of cGMP regulations related to QC laboratories.
• Advanced technical writing skills.

Responsibilities

• Plan, execute, and write laboratory investigations with root cause identification and corrective actions.
• Write and edit SOPs, validation protocols/reports, forms, and technical documents from conception to utilization.
• Proofread documents for content, formatting, and errors.
• Review data pertaining to documents being drafted.
• Participate in gap assessments of technical documentation and propose remediation.

Skills

Analytical writing

GxP knowledge

Root cause analysis

Document control

Technical writing

Quality systems

Communication

Problem solving

Data interpretation

Collaboration

Tools

Microsoft Office

TrackWise

COMET

eLIMS

Job description

Johnson & Johnson in Titusville, NJ seeks a Technical Writer to lead GMP documentation and investigations in the NJ Stability Lab Operations. This role requires technical writing, problem solving, and strong attention to detail.

You will author SOPs, validation protocols, and reports from conception to utilization, review data, provide guidance to investigators, and support Health Authority inspections with clear, compliant documentation.