GLP QA Specialist II: Quality Systems & Documentation

Celldex; Fall River (MA); On-site; USD 76,274 - 99,189; Full time

Job summary

Celldex is seeking a QA professional to maintain GLP document control, manage lab notebooks, and oversee GLP QA periodic reports. The role supports GLP testing, trends GLP QA information, and conducts internal GLP audits, ensuring cGMP compliance.

A BS/BA in Life Sciences and 1–3 years of QA experience in biotech/pharma are preferred, with strong EDMS and MS Office skills. The position offers base compensation with a comprehensive benefits package, including discretionary bonuses and health

Qualifications

• BS/BA in Life Sciences required or preferred; QA experience in Biotech/Pharma is valued.
• 1–3 years QA experience in Biotech/Pharma industry specified as ideal.
• Strong working knowledge of EDMS and GLP/cGMP regulations.
• Proficient in MS Word, Excel, and related databases; strong communication.

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

Attention to detail

Communication skills

Independent worker

Education

Bachelor in Life Sciences (BS/BA)

Tools

EDMS

cGMP/GLP

MS Word/Excel

Job description

Celldex is seeking a QA professional to maintain GLP document control, manage lab notebooks, and oversee GLP QA periodic reports. The role supports GLP testing, trends GLP QA information, and conducts internal GLP audits, ensuring cGMP compliance.

A BS/BA in Life Sciences and 1–3 years of QA experience in biotech/pharma are preferred, with strong EDMS and MS Office skills. The position offers base compensation with a comprehensive benefits package, including discretionary bonuses and health