Senior GMP Technical Writer & Investigations Lead

Biopharma Careers; New Jersey; On-site; USD 79,000 - 128,000; Full time

Benefits offered by this job

401(k) plan

Long-term incentive program

Paid time off

Job summary

Johnson & Johnson is seeking a Senior Technical Writer for the Titusville, NJ location to drive GMP documentation across QC investigations. You will write SOPs, validation reports, and CAPAs while ensuring compliance with FDA, GMP, and internal standards.

You will mentor junior investigators, lead writing activities, and coordinate with QA and lab teams to sustain regulatory readiness and process improvements.

Qualifications

• Detailed knowledge of analytical technologies used in QC lab (HPLC, Dissolution, IR, Karl Fischer).
• Experience in a QC laboratory as bench analyst.
• Advanced technical writing skills and GMP knowledge (cGMP, USP/EP/JP).
• Ability to lead investigations and mentor others in technical writing.

Responsibilities

• Lead writing of GMP documents and investigations in the NJ Stability Lab Operations.
• Plan, execute, and write investigations with root-cause analysis and corrective actions.
• Write and edit SOPs, validation protocols/reports, forms, and analytical documents from conception to utilization.
• Provide training and mentorship to new investigation writers and lab analysts.

Skills

Analytical reasoning

Problem solving

Technical writing

Communication

Cross-functional collaboration

Kepner-Tregoe / 5-Why analysis

MS Office

Quality systems awareness

Education

Bachelor's degree in life sciences or related field

Tools

TrackWise

COMET

DocSpace

TruVault

eLIMS

Job description

Johnson & Johnson is seeking a Senior Technical Writer for the Titusville, NJ location to drive GMP documentation across QC investigations. You will write SOPs, validation reports, and CAPAs while ensuring compliance with FDA, GMP, and internal standards.

You will mentor junior investigators, lead writing activities, and coordinate with QA and lab teams to sustain regulatory readiness and process improvements.