Change & Document Control Specialist (GMP/ISO)

Kelly; Raynham (MA); On-site; USD 60,000 - 90,000; Full time

Benefits offered by this job

Vacation and sick pay

Paid holidays

401(k) plan

Group medical, vision, dental, life, &

Short-term disability insurance

Job summary

Kelly is seeking a Documentation Specialist/Change Analyst in Raynham, MA to manage the Change Order process and ensure compliance with FDA QSR for Documentation and Documentation Control. You will release new and updated controlled documents, coordinate with Change Owners, and drive efficiency while maintaining compliance.

Excellent organizational and communication skills are essential in this role, with exposure to GMP/ISO environments.

Qualifications

• Bachelor degree preferred but not required.
• Minimum one year in GMP/ISO regulated environment required.
• Familiarity with PC-based viewing systems WebView, Product View, Agile.
• Windchill experience desirable.

Responsibilities

• Accountable for administration of the Change Order (CO) process.
• Ensure compliance with FDA QSR as it pertains to Documentation and Control.
• Release of new and changed controlled documents in a timely manner.
• Coordinate workflow with Document Control and Change Owners as needed.
• Maintain and improve processes for document management and compliance.

Skills

Documentation control

Quality/regulatory knowledge

FDA QSR compliance

Communication skills

Team player

Education

Bachelor degree preferred

GMP/ISO environment experience

Tools

WebView

Product View

Agile

Windchill

Job description

Kelly is seeking a Documentation Specialist/Change Analyst in Raynham, MA to manage the Change Order process and ensure compliance with FDA QSR for Documentation and Documentation Control. You will release new and updated controlled documents, coordinate with Change Owners, and drive efficiency while maintaining compliance.

Excellent organizational and communication skills are essential in this role, with exposure to GMP/ISO environments.