Quality Assurance Associate II

About Celldex

Celldex is pioneering new horizons in immunology to deliver life-changing therapies. We are relentless in our pursuit of novel antibody-based treatments that engage the human immune system and directly affect critical pathways to improve the lives of patients with allergic, inflammatory and autoimmune disorders. We have built a culture where innovative and talented people thrive—focusing a significant effort on attracting and retaining passionate and motivated employees who want to play a role in helping people with serious health conditions and who see this effort as personally rewarding. In our highly entrepreneurial environment, employees are empowered and the opportunity for professional development occurs every day.

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.