Quality Supervisor

The Supervisor, Quality Assurance Floor Support will be responsible for overseeing QA support during GMP manufacturing activities at ProKidney’s cGMP Manufacturing sites. This position involves direct supervision of QA floor support personnel and the management of real-time quality assurance functions on the manufacturing floor. The Supervisor will report to the Manager, Quality Assurance Floor Support and play a pivotal role in supporting ProKidney’s expanding CMC development programs.

The role demands strong decision-making skills, independent problem-solving, and the ability to identify and resolve quality issues. This individual will work closely with cross-functional teams including Manufacturing, Quality Control, Supply Chain, and Facilities to ensure consistent quality compliance, while also managing the floor support schedule and training responsibilities.

Essential Duties & Responsibilities:

• Supervise QA Floor Support Team: Oversee direct reports responsible for on-the-floor manufacturing support, real-time documentation review, and troubleshooting issues such as changeovers or deviations.
• Decision-Making & Issue Resolution: Make quality-related decisions that may impact operations, ensuring escalation procedures are followed. Resolve complex manufacturing issues using expertise, professional judgment, and company objectives.
• Team Development & Training: Develop and train direct reports, ensuring they meet required competencies and qualifications. Track and complete all necessary training for floor support personnel.
• Documentation Review & Approval: Review and approve activities performed by direct reports, ensuring compliance with SOPs and regulatory standards.
• Gowning Qualifications: Ensure that all on-the-floor QA personnel are gowning qualified and compliant to support manufacturing activities at all times.
• QA Scheduling: Manage and ensure adherence to the QA floor support schedule, aligning with the manufacturing schedule to guarantee 100% QA presence during all manufacturing activities.
• Walkthroughs & Troubleshooting: Perform routine walkthroughs of the manufacturing suites to partner with manufacturing teams on suite maintenance, implementing quality best practices, and addressing any emerging issues.
• Real-Time Batch Record Review: Conduct real-time reviews of batch records during manufacturing, identifying potential deviations and ensuring they are promptly addressed and reported.
• Documentation Review: Oversee the review of GMP documentation related to manufacturing, including forms, logbooks, testing records, alarm logs (equipment and building management), cleaning activities, and kitting processes.
• Quarantined Materials: Ensure quarantined materials are correctly placed and managed post-manufacturing activities.
• Deviation & Change Control Support: Support, review, and approve deviations and change controls related to operational activities, batch records, or manufacturing improvements.
• SOP, Change Control & Protocol Review: Author or review SOPs, change control documents, and protocols related to cGxP programs as assigned by management.
• Quality Metrics Reporting: Report on key quality metrics as assigned, ensuring accurate and timely tracking.
• Audit Participation: Participate in internal and external regulatory quality assurance audits as directed by Quality Management.
• Project Management: Manage multiple projects and priorities in a fast-paced environment, ensuring alignment with operational goals.
• Compliance Risk Management: Identify compliance risks, communicate them to senior management, and oversee the development and implementation of risk mitigation action plans.
• Escalation of Critical Issues: Identify and escalate critical quality issues to senior management as appropriate.
• Industry Knowledge: Maintain up-to-date knowledge of industry trends, standards, and methodologies as they relate to cGxP and GMP compliance.
• Support Quality System Development: Support the development, implementation, and maintenance of regulated Quality Systems.
• Additional Responsibilities: Perform other activities as assigned by the Manager, Quality Assurance Floor Support.

Minimum Qualifications:

• Qualification:
  • Associate’s Degree + 6 years of relevant experience
  • Bachelor’s + 4 years of relevant experience
  • 2-3 years of supervisory or leadership experience
• Knowledge:
  • Working knowledge of audits and inspections, deviation management, and CAPA resolution
  • Experience in cGMP aseptic manufacturing operations.
  • Demonstrated working knowledge of FDA, EU, and ICH Regulatory requirements and guidelines
• 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.
  • Demonstrates proficiency in conflict resolution
  • Proficient with Microsoft Word, Excel, Adobe