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Sr QA Specialist, Quality Systems and Compliance

Winston-Salem, North Carolina, United States

Join us in developing pioneering therapies that aim to transform the treatment of CKD and change patients’ lives. Our technology is designed to treat diseased kidneys using a patient’s own cells and may prevent or delay dialysis or transplant.

Senior QA Specialist provides the direction/coordination/education/tools needed to develop and maintain an effective Quality Management System (QMS) that is compliant with ProKidney Corporation Policies and Regulatory standards. 

Essential Duties & 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. 

Computer Skills: 

  • Proficiency Microsoft products including Outlook, SharePoint, Word, PowerPoint, and Excel.
  • MasterControl™ (Other EMS System) Supplier/Audit Module experience a plus. 

Education And Experience: 

  • 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. 

Knowledge, Skills, And Abilities 

  • 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.
  • Knowledge of manufacturing processes and safety in GMP regulated facilities.
  • 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. 

 

ProKidney is an Equal Opportunity Employer. All applicants are considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. We are committed to the principles of equal employment opportunity for all employees with a work environment free of discrimination and harassment. 

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