GxP Quality Document Controller (On-Site)

Planet Pharma; Bedford (MA); On-site; USD 34,440 - 48,216; Full time

Job summary

Planet Pharma seeks a Document Control Specialist, Quality, to support document management lifecycle at our Bedford, MA site. The role emphasizes issuing and reconciling GxP documents while maintaining compliance with GDP and cGMP principles.

This CORE on-site position requires handling high volumes of documentation, audits, and collaboration with internal teams to uphold quality systems and regulatory standards.

Qualifications

• Bachelor's degree in a science, engineering, or related discipline.
• 1–4 years' experience in Quality with pharma/biotech or life-sciences exposure a plus.
• Experience in document control and electronic document management systems.

Responsibilities

• Adhere to SOPs, work instructions, and admin practices.
• Manage activities in the Document Storage Room at GTMF and GTQC.
• Organize and archive a high volume of documentation (electronic and paper).
• Assist with organizing and filing documents and records.
• Support issuance of controlled documents and audits/inspections.
• Provide GDP and cGMP guidance during daily activities.
• Communicate to assess interdepartmental needs and priorities.

Skills

Attention to detail

Organizational skills

Independent work

Effective communication

Education

Bachelor's Degree in science/engineering or related discipline

Tools

MS Excel

MS Word

MS PowerPoint

Job description

Planet Pharma seeks a Document Control Specialist, Quality, to support document management lifecycle at our Bedford, MA site. The role emphasizes issuing and reconciling GxP documents while maintaining compliance with GDP and cGMP principles.

This CORE on-site position requires handling high volumes of documentation, audits, and collaboration with internal teams to uphold quality systems and regulatory standards.