GLP QA Specialist II
Celldex Therapeutics•Fall River, MA
•$87,831 - $114,066
About The Position
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.
Requirements
- 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.
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
Benefits
- 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
- sick days
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
