GLP QA Specialist II

Celldex Therapeutics, Inc.; Fall River (MA); On-site; USD 87,831 - 114,066; Full time

Benefits offered by this job

Annual discretionary bonus

Long-term incentive

401(k) plan with employer contribution

Health care and other insurance

Paid holidays

Vacation and sick days

Job summary

Celldex Therapeutics, Inc. is seeking a QA professional to maintain GLP document control, manage lab notebooks, and support QA systems. The role emphasizes accuracy, independence, and cross-functional collaboration to uphold FDA GLP compliance.

Responsibilities include periodic reports, internal audits, and timely dissemination of quality documents. Strong communication and teamwork are essential for success in a fast-paced biotech environment.

Qualifications

• BS/BA in Life Sciences preferred.
• 1–3 years QA experience in biotech/pharma.
• Strong EDMS knowledge.
• Solid knowledge of cGMP/GLP.
• Proficient in MS Word and Excel.
• Ability to work independently and in a team.
• Excellent communication skills.

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.

Skills

QA experience

Attention to detail

Excellent communication

Team collaboration

Education

BS/BA in Life Sciences

Tools

EDMS

Job description

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.

Compensation The expected base salary range for this position is $87,831 to $114,066

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.