Sr QA Specialist

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.