Position Summary:

This on-site Quality Assurance On the Floor (OTF) Specialist II reports directly to the Manager, QA Floor Support. This position will be based at our cGMP Manufacturing site and will directly support the CMC clinical manufacturing program. The main responsibility for this position is to provide real-time on the floor quality oversight of all Manufacturing activities, with a focus on adherence to aseptic technique, GMP principles during processing, batch record review, and deviations. Strong decision-making skills and independent thinking will be paramount for candidate success. The individual will work closely with Manufacturing, Quality Control, Validation, Supply Chain and Facility teams.

Essential Duties & 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

Education And Experience:

• Bachelor’s degree in applied science.
• 2+ years’ relevant experience with working in Quality Assurance, ideally within cGMP aseptic manufacturing operations.
• Preferred experience in cell or gene therapy.
• 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.