Full-Time

Sr QA Specialist

Quality Systems and Compliance

Confirmed live in the last 24 hours

ProKidney

ProKidney

51-200 employees

Develops cell therapy for chronic kidney disease

Biotechnology
Healthcare

Senior

Winston-Salem, NC, USA

Category
QA & Testing
Quality Assurance
Required Skills
Word/Pages/Docs
Data Analysis
Excel/Numbers/Sheets
PowerPoint/Keynote/Slides
Requirements
  • Bachelor of Science degree in a scientific discipline, or equivalent work experience
  • Minimum of 5 years of experience working in a GxP regulated environment required (minimally 21 CFR 210, 211, Part 11)
  • Experience with conducting/participating in Audits (authorities, suppliers)
  • Certification of Supplier Quality Assurance a plus
  • Proficiency Microsoft products including Outlook, SharePoint, Word, PowerPoint, and Excel
  • MasterControl™ (Other EMS System) Supplier/Audit Module experience a plus
Responsibilities
  • Perform vendor audits and assessments, ensuring proper execution and documentation of any supplier-related controls and/or hazards within the material/product risk assessment.
  • Support 3rd Party Supplier Program, Certifications, Audits, Quality Agreements, and CAPAs
  • Support all inbound supply risks including vendor complaints and vendor change notifications.
  • Perform internal audits of cross-functional departments, ensuring oversight of compliance with internal procedures and relevant regulations.
  • Supporting Quality Systems with data analysis as required monitoring supplier performance and project deliverables.
  • Participates in internal customer and external regulatory quality assurance audits as directed by Quality Senior Leadership.
  • Review and approve Quality System documentation (including but not limited to deviations, change controls, Out-of-Specification, and Out-of-Limit investigations) in accordance with established procedures and regulatory compliance requirements.
  • Lead and/or work in cross-functional teams to complete projects, address quality issues, and implement quality systems improvements.
  • Support Quality Risk Management program.
  • Initiate, investigate, and/or own investigations and/or CAPAs initiated in response to Quality Assurance events.
  • Other duties as assigned by Manager.

ProKidney focuses on developing a new treatment for Chronic Kidney Disease (CKD) using a cell therapy called rilparencel. This therapy aims to help preserve kidney function in patients with advanced CKD, potentially delaying or eliminating the need for dialysis, which is often the only option for these patients. ProKidney is currently in the late stages of clinical trials, and early results indicate that rilparencel may effectively maintain kidney function. What sets ProKidney apart from its competitors is its specific focus on CKD and its unique approach to treatment through cell therapy, targeting a significant and underserved patient population. The company's goal is to provide a groundbreaking alternative to dialysis, improving the quality of life for millions of CKD patients. Once rilparencel receives regulatory approval, ProKidney plans to sell and distribute the therapy to healthcare providers and patients, ensuring broad access to this important treatment.

Company Stage

IPO

Total Funding

$559.3M

Headquarters

Winston-Salem, North Carolina

Founded

2015

Growth & Insights
Headcount

6 month growth

1%

1 year growth

0%

2 year growth

-1%
Simplify Jobs

Simplify's Take

What believers are saying

  • ProKidney raised $140 million, boosting clinical trials and R&D for rilparencel.
  • The FDA's approval of similar therapies may ease rilparencel's regulatory pathway.
  • Growing personalized medicine trends favor ProKidney's cell therapy approach.

What critics are saying

  • ProKidney's canceled Greensboro expansion may harm its reputation and stakeholder trust.
  • Increased manufacturing expenses could strain financial resources, affecting development pace.
  • Reliance on public offerings for capital may indicate potential cash flow issues.

What makes ProKidney unique

  • ProKidney is pioneering rilparencel, a novel cell therapy for CKD.
  • Rilparencel aims to delay or eliminate the need for dialysis in CKD patients.
  • ProKidney targets an underserved CKD market, addressing a critical treatment gap.

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