GMP Documentation Specialist - Quality Systems

Planet Pharma; Pennington (NJ); On-site; USD 28,000 - 34,000; Full time

Job summary

Planet Pharma is seeking a Document Control Specialist to manage and maintain records supporting the Quality Management System across product development and business activities.

You will support the Quality and Regulatory team, ensuring controlled documents lifecycle, version control, archival, and retrieval in a GMP environment. This role requires strong communication and proficiency with electronic document systems.

Qualifications

• Bachelor in a Life Science discipline or equivalent (4+ yrs industry experience).
• Minimum of 2 years of experience in direct control of GMP systems and documentation.
• Knowledge of GMPs, FDA regulations, and documentation procedures.

Responsibilities

• Manage day-to-day operations in Document Control.
• Issue working records for production and QC.
• Archive completed, scanned records; manage True Copy activities.
• Implement new document archive procedures and write related procedures.

Skills

GMP knowledge

FDA regulations

Electronic document systems

MS Office

Adobe Acrobat

Written and verbal communication

Education

Bachelor in Life Science or equivalent

Tools

QDMS

LMS

EDMS

E-Doc

Job description

Planet Pharma is seeking a Document Control Specialist to manage and maintain records supporting the Quality Management System across product development and business activities.

You will support the Quality and Regulatory team, ensuring controlled documents lifecycle, version control, archival, and retrieval in a GMP environment. This role requires strong communication and proficiency with electronic document systems.