GLP QA Specialist II

GLP QA Specialist II Job Locations US-MA-Fall River 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 $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 Options Apply for this job online Apply Share Refer this job to a friend Refer Sorry the Share function is not working properly at this moment.

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