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.
...Job Summary: Our client is seeking a Mainframe Programmer to join their team! This position is located in Brookfield, Wisconsin. Duties: Split time between developing new functionality to support ICS testing environments and providing production support for jobs...
...Security Officer Luxury Retail (NYC) Were seeking a professional Security Officer to support the safety of customers, employees, and merchandise in a luxury retail environment. This role focuses on theft prevention, emergency response, and asset protection, while...
...living facility, is seeking compassionate, patient, and dedicated Caregivers to join our team. We have full-time and part-time opportunities... ..., such as bathing, dressing, and grooming Document resident care and progress Build strong relationships with residents and...
...Recruiting Company TAPI Japan LTD Who we are At TAPI, were not just a companywere a community committed to advancing... ...health from the core. As the worlds leading supplier of active pharmaceutical ingredients (APIs), we partner with 80% of the top 50 global...
...community in our work. We help keep Utah connected and understand that people are at the center of the UTA Way.We are looking for a Director of Total Rewards to lead UTAs Total Rewards department. Under the direction of the Chief People Officer, the Director of Total...