GLP QA Specialist II

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

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 $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