Job Description

Requirements:

-Bachelor's degree in Scientific field

-Minimum 2 years of experience working in a GMP manufacturing environment

-Minimum 1 year of experience performing investigations

-Experience with technical writing and written investigations with appropriate grammar

-Experience with quality document reviews and regulatory inspection processes required

-Team player attitude

Preferred:

-Prior experience supporting deviations, root cause analysis and CAPA activities

-Cleanroom experience – gowning requirement, ISO standards

-Working knowledge of quality event management systems such as Trackwise and Investigation Tools such as pareto and Ishikawa analysis

-Experience with Quality Event Management Systems such as Trackwise, COMET, and other QEM applications/systems

-Familiarity with cell and gene therapy modalities

Job description:

Our large pharmaceutical client is currently seeking a GMP Investigator to join their growing Cell Banking team within their R&D group in Malvern, PA. As an Investigator, you will be responsible for independently supporting simple, moderate, and complex investigations to ensure product quality. You’ll be providing quality review of GMP documentation related to the support of QC and R&D, as well as Engineering activities by reviewing and approving protocols, reports, SOPs, and change controls for appropriateness, completeness, and alignment with quality, validation and regulatory expectations. You will also be reviewing and approving lab-related deviations and resulting investigation reports, corrective actions, and/or preventive actions.

Responsibilities will include:

- Opens and manages quality issues and investigations for GMP operations in Cell Banking.

- Performs various root-cause problem solving activities to determine underlying causes for quality issues and investigations.

- Performs identification of effective corrective and preventative actions.

- Initiates and Execute CAPAs & corrections as result of investigations.

- Support compliance initiatives within the manufacturing laboratory areas and within Cell Banking including, but not limited to: QRAs, Change Controls, Commitment Records, Test Records, Quality Issues, & Commitment Records.

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