GLP QA Specialist 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

This role is responsible for maintaining quality systems, tracking and reporting QA metrics, managing laboratory documentation processes, and ensuring adherence to FDA GLP requirements while partnering with cross-functional teams to drive continuous improvement and quality excellence. The ideal candidate is detail-oriented, highly organized, and capable of working independently and collaboratively to support the integrity, accuracy, and compliance of quality operations across the organization.

Responsibilities

• Maintain GLP document control system including preparing, updating, formatting, distributing, issuing, and tracking GXP documents
• Manage, distribution, and reconciliation of laboratory notebooks
• Manage GLP QA periodic reports
• Assist in GLP QA systems execution supporting GLP testing
• Create, trend, and report GLP QA Quality Systems information
• Perform internal GLP audits

Qualifications

• Bachelor Science (BS)/Bachelor Arts (BA) degree in Life Sciences preferable.

• 1-3 years QA experience in Biotech/Pharma industry.

• Strong working knowledge of EDMS (electronic document management system)

• Strong working knowledge of cGMP/GLP.

• Strong working knowledge of MS Word,  Excel and related databases
• The ability to work independently and as part of a team
• Excellent communication skills.

CompensationThe expected base salary range for this position is $76,374 to $99,189

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.

Compensation for this role 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