GMP QA Documentation Specialist

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

Job summary

Celldex in Fall River, MA is seeking a Quality Assurance Associate II to perform documentation activities for manufacturing operations, ensuring compliance with GXP quality systems. The role emphasizes document control, EDMS workflows, and maintaining records.

The candidate will support raw material and product release, assist with internal and external audits, and contribute to training documentation in SharePoint while maintaining confidentiality and deadlines.

Qualifications

• Experience with GMP/GxP quality systems is required.
• Proficiency with MS Office Suite and document control tools.
• Excellent written and verbal communication skills.

Responsibilities

• Document Management workflow coordination for GMP/GxP documentation.
• Format, review and issue batch records and related documents.
• Assign raw material part numbers and support material/product release.
• Generate labels and maintain labeling inventory and equipment upkeep.
• Write/revise QA SOPs and QA reports; archive and scan records.
• Support internal and external audits and training documentation.

Skills

MS Office Suite

Strong communication

Organizational skills

Education

Associate Degree

Tools

EDMS

Job description

Celldex in Fall River, MA is seeking a Quality Assurance Associate II to perform documentation activities for manufacturing operations, ensuring compliance with GXP quality systems. The role emphasizes document control, EDMS workflows, and maintaining records.

The candidate will support raw material and product release, assist with internal and external audits, and contribute to training documentation in SharePoint while maintaining confidentiality and deadlines.