09 Aug
Quality Assurance Inspector
Pennsylvania, Philadelphia

An established and growing Bio-Tech company in Philadelphia is looking to add a few members to their Quality Team. Interested candidates can apply through this posting or may send their resumes to Donna Faulkner at dfaulkner@jouleinc.com
Title
Location South Philadelphia
Job Description
Quality Assurance Material Specialist
Performing quality functions associated with the disposition of raw materials, components and reagents used in manufacturing operations and quality control testing of its products.
Responsibilities include but are not limited to:
Maintaining strong attention to detail in the review of records for completeness and accuracy. Record types include, but are not limited to:
Material Receipt Forms/Log
Materials Disposition Forms/Logs
Chain of Custody records
Supplier documentation (e.g. CofA's, CofCs, etc.)
Test data related to material disposition
Equipment Logbooks
GMP Cleaning Records
Other documents assigned
Ensuring materials meet specification prior to QA release for use in GMP manufacturing operations.
Correct and accurate completion of records/forms/logs in accordance with Adaptimmune policies.
Generation and reconciliation of accurate labels used in the materials disposition process.
Providing input and assisting on revision to materials receipt processes and raw material specifications Responsible to exercise judgment to determine appropriate corrective actions and when to escalate issues to Supervisor.
Provide Primary Quality oversight of cGMP shipments
Assist Quality Assurance in product review, CAPA, root cause analysis, audits and other QA functions
Responsible to prioritize activities to ensure timely release and availability of materials.
Responsible to develop and maintain productive relationships with other Adaptimmune Employees, and to prioritize, plan and use time efficiently.
Other duties as assigned
Minimum Requirements:
Bachelor's degree in a scientific discipline with 1-2 years of work experience in Quality Assurance in a GMP regulated environment or equivalent (Associate’s Degree + 4 years pharmaceutical QA GMP experience or high school diploma + 8 years of pharmaceutical QA GMP experience.
0-2 years’ work experience in warehouse or materials management
Experience with cleanroom operations or sterile/aseptic technique
Familiarity with GMP inventory control databases/MRP systems a plus
Proficiency with Microsoft Office and Outlook.


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