Good Clinical Practices Auditor
This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. This role is full-time and is offering full benefit options. As a Kelly FSP employee you may be eligible for Medical, Dental, Vison, 401K, and a variety of other benefits to choose from. You may also be eligible for paid time off, including holiday, vacation, and sick/personal time. Performs all GMP Operations investigations. Perform various root cause problem solving activities to determine root cause for investigation and to identify effective corrective and preventative action. Initiate/Execute CAPAs as result of quality investigations.
Minimum 2 years related experience in a pharmaceutical industry required.
Experience with Quality document reviews and regulatory inspection processes.
Working knowledge of Quality systems (ETS) and Investigation tools
cGMP experience required
Knowledge of 21CFR Parts 210, 211, European Guidance on Advance Therapies preferred.
Great time management
Strong writing skills
Documentation/Reporting
Cell and Gene therapy modalities
Verbal communication
written communication
flexibility
Organizational skills
Problem Solving Skills
Attention to detail and accuracy
Multi tasker
According to JobzMall, the average salary range for a Good Clinical Practices Auditor in Spring House, PA, USA is $64,357 to $113,826 per year.
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Kelly Services, Inc. is an American office staffing company that operates globally. The company places employees at all levels in various sectors including financial services, information technology, and law.
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