Quality Assurance Associate II

About the role

Celldex, a biotechnology company developing antibody-based immunology therapies, is hiring a Quality Assurance Associate II in Fall River, Massachusetts. The associate performs documentation activities linked to manufacturing operations while ensuring compliance with GXP quality systems.

Key responsibilities

• Coordinate the Electronic Document Management System (EDMS) workflow for GMP and other GxP documentation, format and review documents, and support attachment issuance such as batch records, solution records and validation testing documentation
• Assign raw material part numbers, support raw material and product release, generate labels, and maintain label and ribbon inventory and labeling machine maintenance schedules
• Write or revise QA SOPs and reports, maintain, scan and archive QA documentation, and report vendor change notifications on their effect on manufacturing
• Organize and maintain off-site storage shipments for Fall River, and support internal training, including off-site storage preparation, and keep training files in SharePoint
• Conduct annual documentation audits, support internal GMP audits and external audit documentation requests

Required profile

• Associate degree with 2+ years of GMP experience, or 4+ years of GMP experience without a degree
• Broad knowledge of GMP and other GxP quality systems, policies and regulations
• Ability to multi-task, prioritize work proactively, take initiative, keep confidential information, meet deadlines and work independently and in a team

Required skills

• Document management experience in a GMP environment preferred
• Proficiency with MS Office Suite
• Proficiency with an EDMS

What we offer

• Expected base salary of $66,413 to $86,250
• Possible annual discretionary bonus and long-term incentive
• 401(k) plan with employer contribution
• Health care and other insurance benefits for employee and family, paid holidays, vacation and sick days