• GMP Investigator

    Insight Global (Malvern, PA)


    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. Youll 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.

     

    We are a company committed to creating inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity employer that believes everyone matters. Qualified candidates will receive consideration for employment opportunities without regard to race, religion, sex, age, marital status, national origin, sexual orientation, citizenship status, disability, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to Human Resources Request Form (https://airtable.com/app21VjYyxLDIX0ez/shrOg4IQS1J6dRiMo) . The EEOC "Know Your Rights" Poster is available here (https://www.eeoc.gov/sites/default/files/2023-06/22-088\_EEOC\_KnowYourRights6.12ScreenRdr.pdf) .

     

    To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/ .

     

    Skills and 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 -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 null

    We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion,sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military oruniformed service member status, or any other status or characteristic protected by applicable laws, regulations, andordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to [email protected].