Join to apply for the USA - CAPA Investigator Owner role at Planet Pharma
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Overview
Join to apply for the USA - CAPA Investigator Owner role at Planet Pharma
Responsibilities
- Perform non-conformance (NCR) investigations within the Track Wise 8 Management System.
- Execute implementation of CAPAs associated with NCR investigations.
- Maintain a high level of expertise in current regulatory requirements, and serve as a plant resource for compliance to these requirements. Maintain audit ready status for assigned areas and assist other areas within the facility in maintaining compliance with local procedures as well as US & International Regulatory and corporate quality requirements.
- Provide guidance and coaching on the performance of DMAIC problem solving and process improvement projects for less experienced individuals within the plant.
Pay range : 57-67 / hr
Qualifications
Candidate must not be allergic to Penicillins or CephalosporinsUnderstanding of the products intended use and manufacturing processAbility to prioritize multiple tasks to ensure compliance with regulations and standard operating proceduresStrong problem solving and analytical skillsConsultation and facilitation skillsUnderstanding of statistics in support of fact based decision makingExcellent written / verbal communication and organizational skillsAbility to make independent decisions with minimum oversightCustomer sensitivity / acumen and ability to interact with all levels of managementExperienced user of TrackWise preferredWorking knowledge of FDA Regulations and International Regulatory requirementsUnderstanding of risk management toolsAvailable to work during off-shift or weekends as appropriate to support investigations and trainingEducation And / or Experience
BS / BA (4 years of university level education) in science, engineering or related field2-4 years relevant work experience in cGMP related industry or in a clinical settingGreenbelt certification or equivalent experience using Six Sigma or other Lean Manufacturing tools is a plusThe Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
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