QA Specialist 2

The QA Specialist 2, Quality Systems is an integral part of the overall ProKidney Quality team, contributing to our success by being responsible for the progression of compliant documentation detailing Quality Events to support regulatory compliance with cGMP regulations.

This position requires a firm comprehension of global cGMP regulations, supporting the development, implementation, and maintenance of GMP Quality Management Systems at ProKidney. This rolecontributes to guidance of quality system components to support the manufacture and clinical study of ProKidney products in a manner that is compliant with global and internal compliance requirements. Participates in Quality Event investigations in accordance with federal and international regulations and standards to ensure the identification and mitigation of potential risks associated with Quality events. Ensures compliance with the company’s quality management system.

Essential Duties and Responsibilities:

• Contribute to continuous improvement of Quality Systems, such as Deviations, CAPAs, investigations, Out-of-Specifications, and Out-of-Limits, and direct the efforts to develop, implement, and maintain compliant and effective Quality Systems.

• Contribute to Quality Systems by driving regulatory compliance and continuous improvement activities in accordance with applicable regulations and business goals and objectives.

• Contribute to solutions and drive risk analysis and mitigation strategies in response to Quality events at ProKidney to assure timely distribution of Clinical Drug Product.

• Provide technical expertise for quality decisions.

• Contribute to development, maintenance, and management of Quality Systems.

• Contribute to quality systems improvement initiatives by working closely with site leaders and other key stakeholders.

• Contribute to Quality System documentation in accordance with established procedures and regulatory compliance requirements.

• Work in cross-functional teams to complete projects, address quality issues, and implement quality systems improvements.

• Supports the development, implementation, and management of training associated with Quality System investigations.

• Supports identification and implementation of continuous improvement opportunities as well as interfacing with other functional areas including manufacturing, facilities, Quality Control, and other Quality department projects/activities.

• Maintain departmental GMP databases to ensure consistent data, tracking, and follow- up.

• Performs hands-on monitoring of production and non-production activities and notifies area and Quality Management of any observed non-compliance.

• Participates in internal customer and external regulatory quality assurance audits as directed by Quality Senior Leadership.

• Collaborates with internal departments on strategy and implementation of quality principles and regulation requirements.

• Identifies and escalates critical quality issues appropriately to senior management.

• Maintains effective cross functional team communications to advance quality activities while remaining independent and autonomous.

• Maintains a contemporary knowledge of current industry trends, standards and methodologies as it relates to cGxPs

• Support the development and implementation of regulated Quality System

Knowledge, Skills, and Abilities:

• Understanding of laboratory, manufacturing, packaging, regulatory affairs, compliance, clinical, and quality assurance requirements for biological and product manufacturing.

• Knowledge of plant quality systems, plant data systems, investigation and mitigation of impact associated with Quality Events, and corporate metrics.

• Strong attention to detail.

• Ability to read, understand, interpret, and apply technical writing and instructions.

• Ability to write reports, business correspondence, and procedures.

• Ability to define problems, collect data, establish facts, and draw valid conclusions.

• Knowledge of manufacturing, spreadsheet, and word processing software.

• Knowledge and experience in using MasterControl electronic Quality Management system for documentation of Quality Events and maintenance of approved procedures is a plus.

Education and Experience:

• Bachelor’s degree in science or relevant field or equivalent experience required.

• 3+ years applicable experience in a regulated medical environment required.

• Knowledge of industry guideline including cGMP, validations/qualifications, regulatory guidelines (i.e., FDA, EU, ICH, ISO), and handling of regulatory inspections.

• Demonstrated ability to analyze, investigate, and propose approaches to quality and regulatory issues.

• Technical writing background; able to read/analyze/interpret common scientific/technical documents.

• Solid judgement and decision making in complex situations.

• Highly ethical and transparent, with professional sensitivity and care for confidentiality.

• Excellent written/verbal communications with ability to influence effectively at all levels within organization.

• Excellent MS Office (Word, Microsoft Excel, and Power Point) required.