ProKidney Corp. · 1 month ago
Investigator, Mfg Compliance (Contract)
Winston-Salem, North Carolina, United States
Contract
Onsite
Senior Level
5+ years expProKidney is a company focused on maintaining quality systems and cGMP compliance. The Technical Investigator is responsible for the initiation, investigation, and completion of process deviations, Change Controls, and CAPA’s, ensuring compliance with safety and quality standards.
Health CareTherapeutics
No H1B
Responsibilities
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
Qualification
Required
Undergraduate degree in science discipline
5+ years' experience in a Cell Therapy environment in the department hired
Strong organizational skills and record keeping with the ability to work overtime when needed
Ability to engage and interview co-workers to obtain relevant information pertaining to investigations
Strong attention to detail and organizational skills
Strong communication skills (written and oral)
Independent and self-motivated
Familiarity with cGMP quality systems
Ability to read and comprehend GMP documents (i.e. SOPs, logs, and Batch Records)
Strong typing and computer skills, including efficiency using Microsoft Office Suite (Word, Excel, PowerPoint)
Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship
Company
ProKidney Corp.
ProKidney, a pioneer in the treatment of chronic kidney disease through innovations in cellular therapy, was founded in 2015 after a decade of research.
51-200 employees
Funding
Current Stage
Public CompanyTotal Funding
$345MKey Investors
Social Capital
2024-06-11Post Ipo Equity· $140M
2022-07-12Post Ipo Equity· $205M
2022-07-12IPO
Leadership Team
Bruce Culleton
Chief Executive Officer
Recent News
2026-01-06
2026-01-03
Company data provided by crunchbase