Quality Assurance 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

Overview

The Quality Assurance Associate II performs documentation activities associated with manufacturing operations while ensuring compliance with GXP quality systems.

Responsibilities

• Document Management
  • Electronic Document Management System (EDMS) workflow coordinator for GMP documentation and other GxP documentation, as needed
  • Document formatting and review
  • Attachment issuance support, that includes, but is not limited to, issuing and reconciling Batch Records, Solution Records and Validation Testing documentation and maintaining tracking tools, both hard copy and electronic
  • Assignment of raw material part numbers
  • Support raw material and product release
  • Label generation
  • Maintenance of label and ribbon inventory and scheduling annual maintenance of labeling machines
  • Write/revise QA SOPs and reports, as related to document control
  • Maintain, scan and archive Quality Assurance documentation
  • Report on Vendor Change Notifications to determine their effects, if any, on manufacturing
  • Responsible for organizing and maintaining off-site storage shipments for Fall River
• Training Program Support
  • Perform internal training, including, but not limited to, off-site storage preparation
  • Maintain training documentation including the hard copies and the electronic training files in SharePoint, as needed
  • Assist with the annual audit of training files
• Auditor
  • Conduct annual documentation audits
  • Support internal GMP audits
  • Support external audit documentation requests
• Other related job functions and QA support as needed

Qualifications

• Associate Degree with 2+ years GMP experience or 4+ years GMP experience without a degree
• Document Management experience in GMP environment preferred
• Broad knowledge of GMP and other GxP quality systems, policies, and regulations
• Strong communication and organizational skills
• Proficiency using MS Office Suite
• Proficiency using an EDMS
• The ability to multi-task and manage and prioritize workload in a proactive manner
• The ability to take initiative, maintain confidentiality, meet deadlines, and work independently and as part of a team

Compensation Statement

The expected base salary for this position is: $66413.00 to $86250.00. We are committed to compensating employees equitably based on several factors including experience, education, licensure/certifications, skill level, location of the position, and availability of similar talent in a competitive market. Subject to eligibility and applicable plan terms, compensation includes base salary, annual discretionary bonus, 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. A summary of our benefits can be found on our careers page Celldex is proud to be an equal opportunity employer that strives to foster a culture of diversity, equity, and inclusion. We are committed to promoting a diverse environment through development, recruiting and community outreach.