GLP QA Specialist II - Elevate Quality Systems & Compliance

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

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.