ProKidney Corp. · 3 months ago
QA Specialist 2
Winston-Salem, NC
Full-time
Onsite
Entry, Mid Level
2+ years expProKidney Corp. is a company focused on cGMP manufacturing, and they are seeking a QA Specialist 2 to provide quality oversight on the manufacturing floor. The role involves ensuring adherence to GMP principles, reviewing batch records, and supporting manufacturing operations.
Health CareTherapeutics
No H1B
Responsibilities
Provide quality on-the-floor support of manufacturing processes, reviewing batch record documentation, and providing real-time support of manufacturing, issues, changeovers etc
Participate in quality oversight of manufacturing through real-time observations of activities. Provide guidance on GMP principles and aseptic technique during routine operations
Enforce adherence to current good manufacturing practices, standard operating procedures, and manufacturing documentation. Establish and follow written procedures for the clear and accurate documentation of equipment operation and process instructions, and of process data
Perform routine walkthroughs of the manufacturing suites partnering with manufacturing on suite maintenance, Quality best practice implementation and troubleshooting when problems arise
Perform review of Environmental Monitoring results associated with GMP operations
Support quality decisions that may impact operations, ensuring appropriate escalation
Identify risks and communicate gaps for quality and GMP process/systems
Review and approve facility alarms, facility work order requests, inventory requests, batch record requests, and return-to-service documentation
Supports, reviews and approves Deviations and Change Controls
Identify risks and communicate gaps for quality and GMP process/systems
Make quality decisions that may impact operations, ensuring appropriate escalation to management when needed
Partners with manufacturing and support teams to initiate and triage new deviation events, reviews minor and major manufacturing deviations
Oversees execution of remediation/CAPA activities required to continue production or move a process to the next milestone
Ability to manage multiple assignments and/or projects in a fast-paced environment
Collaborate and lead effectively in a dynamic, cross-functional matrix environment
Authors and reviews SOPs, policies to ensure compliance and adherence to regulations/cGMP operations
Participate in quality focused teams across ProKidney’s broad ecosystem of functions
Support internal audits
Collaborate with Manufacturing and Quality Operations to ensure appropriate and rapid disposition of clinical products
Demonstrate general knowledge of standard manufacturing compliance, quality disposition, quality system review
Utilize knowledge to improve operational efficiency
Work closely with others to recognize opportunities for improvement and drive change through the use of Quality systems
All other duties as assigned
Qualification
Required
Bachelor's degree in applied science
2+ years' relevant experience with working in Quality Assurance, ideally within cGMP aseptic manufacturing operations
Weekend work may be required based on business needs
Strong organizational, analytical, and time management skills
Ability to work well in a team environment with a positive attitude that is willing to assist other areas of the organization
Excellent verbal and written communication skills as well as strong focus and attention to detail
Demonstrate ability to handle multiple tasks at one time and maintain a strong attention to detail
Ability to perform frequent physical tasks with strength and mobility
Flexible scheduling required
Any equivalency combination of education, experience, and training may substitute
Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship
Preferred
Preferred experience in cell or gene therapy
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
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