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QA Specialist

Edison-New Brunswick Metro Area, NJ

Posted: 10/21/2019 Job Type: Scientific Job Number: JN -102019-25851

Job Description

QA Specialist


Must have advanced knowledge and experience with cGMP manufacturing, Quality, and compliance.

Directs quality initiatives that accomplish continuous improvement and enhance site quality system efficiencies.

Must be action-oriented and customer-focused and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking.

Confident in making decisions for non-routine issues.

Routinely recognizes and resolves Quality issues;

Develops procedures.

Understands continuous improvement and improves efficiency and productivity within the group or project.

Knowledge of US and global cGMP requirements.

Perform QA manufacturing floor activities.

Ensure manufacturing compliance with applicable procedures and batch records.

Perform real time review of manufacturing batch records.

Review manufacturing shop floor documentation.

Issue production batch records and product labels to Operations.

Knowledge of quality processes, including material disposition, change control, product complaints, deviations, investigations, and CAPA management.

Able to effectively multi-task.


This position will provide 12 hour coverage including nights/ weekends.


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