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
Data Analysis

You match the following ProKidney's candidate preferences

Employers are more likely to interview you if you match these preferences:

Degree
Experience
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
  • Must demonstrate excellent problem-solving ability, technical writing skills, good communication skills, and teamwork
  • Knowledge of manufacturing processes and safety in GMP regulated facilities - Pharmaceutical/Medical Device/Biotechnology
  • Must be flexible and able to adapt to company growth and evolving responsibilities
  • Ability to multi-task and manage multiple projects with shifting priorities in a fast-paced manufacturing environment
  • Demonstrate understanding of cGMP, GDP, and QMS
  • Ability to learn and understand technical aspects within documentation
  • Ability to maintain positive cross-functional and collaborative relationships
  • Strong communication skills, including both verbal and written
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
Desired Qualifications
  • MasterControl™ (Other EMS System) Supplier/Audit Module experience a plus
  • Certification of Supplier Quality Assurance a plus

ProKidney focuses on treating Chronic Kidney Disease (CKD) through a novel cell therapy called rilparencel. This therapy aims to preserve kidney function in patients with advanced CKD, potentially delaying or eliminating the need for dialysis, which many patients currently rely on. ProKidney is in the late stages of clinical trials for rilparencel, with early data indicating its effectiveness in maintaining kidney function. Unlike other treatments, ProKidney specifically targets CKD, a condition affecting over 35 million adults in the U.S., and aims to fill a significant gap in available therapies. The company's goal is to provide a groundbreaking treatment that improves the quality of life for CKD patients and reduces their reliance on dialysis.

Company Stage

IPO

Total Funding

$559.3M

Headquarters

Winston-Salem, North Carolina

Founded

2015

Growth & Insights
Headcount

6 month growth

2%

1 year growth

-1%

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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