Investigator, MFG Compliance
ProKidney
This listing was originally posted on ProKidney's careers page. Formulate is an equal opportunity job aggregator and is not involved in the hiring process. Where salary information is estimated, it is derived from BLS industry benchmarks and may differ from actual compensation.
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Upgrade to Pro — $25/moThe Technical Investigator is responsible for the initiation, investigation and completion of process deviations, Change Controls, and CAPA’s for the assigned department. The incumbent is responsible for completion of process deviations with the aim at identification of root cause, determining any product quality impact and implementation of corrective actions to prevent recurrence. They will also be responsible for drafting and managing Departmental Change Controls
• Technical writing for the educated reader, translate moderate to complex scientific events into a brief and cohesive report as a finished product. Accurately capture immediate actions and containment of the event, address comments from both internal and external clients on the compiled final report.
• Gathering Data from various sources across the site, performance of Root Cause Analysis to determine the most likely cause of the deviation investigation, assessment of event for impact to Safety, Identity, Strength, Quality, Purity, perform trending analysis, identification of Corrective and Preventative Actions to reduce deviation recurrence, performance of Risk Assessments, Causing Mapping, Interviewing.
• Management of multiple projects and timelines concurrently. Ability to adhere to standard timeline and escalate actions appropriately for resolution in a timely manner.
• Work with the appropriate department(s) for data gathering, observing processes for investigations, and performance of associate interviews.
• Meeting Facilitation and participation, aligning internal team and area subject matter experts on an agreed investigational path forward. Conflict resolution, problem solving in a cross functional setting, and ability to keep the meeting on track to achieve objective.
• Understand Regulatory requirements around Cell Therapy processing.
• Able to lead and track Change controls through the process ensuring timely completion.
• Perform other duties as assigned.
Requirements:
ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.
Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.
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BIOTECHNOLOGY
Autologous Kidney Cell Therapy
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