GMP Documentation & QA Compliance Associate II

Celldex Therapeutics, Inc.; Fall River (MA); On-site; USD 66,000 - 86,000; Full time

Job summary

Celldex Therapeutics, Inc. in Fall River, MA seeks a Quality Assurance Associate II to manage GMP documentation with EDMS workflows, format and issue records, and support material release. You’ll maintain labeling, SOPs, and training files while assisting with audits and off-site storage logistics.

The role requires GMP experience, strong organization, and proficiency with MS Office and EDMS in a fast-paced QA environment.

Qualifications

• The candidate has GMP/GxP documentation experience and strong Microsoft Office skills.
• Experience with document management and EDMS preferred.
• Ability to work independently and meet deadlines in a GMP environment.

Responsibilities

• Coordinate EDMS workflow for GMP documentation and related GxP docs.
• Format, review, and issue attachments such as batch and solution records.
• Assign raw material part numbers and support material release.
• Maintain label inventory and annual labeling machine maintenance.
• Write/revise QA SOPs and reports related to document control.
• Archive QA documentation and report vendor change notifications.
• Organize off-site storage shipments for Fall River.
• Perform internal training and maintain training documentation.
• Support annual audits and external audit requests.

Skills

Multitasking

Independent worker

Team collaboration

Strong communication

Organizational skills

Education

Associate Degree with GMP experience (2+ years)

GMP experience without degree (4+ years)

Tools

MS Office Suite

EDMS

Job description

Celldex Therapeutics, Inc. in Fall River, MA seeks a Quality Assurance Associate II to manage GMP documentation with EDMS workflows, format and issue records, and support material release. You’ll maintain labeling, SOPs, and training files while assisting with audits and off-site storage logistics.

The role requires GMP experience, strong organization, and proficiency with MS Office and EDMS in a fast-paced QA environment.