QC Microbiology Analyst 3

Essential Duties and Responsibilities

• Perform Change Control and CAPA investigations, ensuring timely closure, impact assessments, and regulatory compliance.
• Support and internal and external audits.
• Generate and present metrics and trends for Management Review.
• Support training on Good Documentation Practices, Data Integrity, and Change Management.
• Review and maintain SOPs, Work Instructions, Validation studies, Risk Assessments and protocols.
• Participate in continuous improvement initiatives, harmonization efforts, and risk assessments related to quality control.
• Perform Routine Environmental Monitoring (EM) of classified GMP areas
• Conduct Personnel Monitoring during Aseptic Manufacturing Operations and EMPQ activities
• Operate, maintain and troubleshoot EM and laboratory equipment
• Adhere to Standard Operating Procedures (SOPs), Work Instructions (WIs), Protocols and safety requirements and document laboratory work consistent with cGMP requirements
• Participate in revising, and training on SOPs, WIs, Forms, and Protocols
• Support lean initiatives in the area of lab operations, standard work, test method execution, documentation updates and equipment qualification

Minimum Qualifications

• Education/Training: Bachelor’s degree in a science or technical discipline preferred, or equivalent experience.
• Experience: 3-5 years of progressive experience in quality systems within regulated pharma, biotech, or medical device industries. Experience with commercial manufacturing and cleanroom monitoring strongly preferred.
• Knowledge: Strong working knowledge of quality systems operations (Deviations, CAPA, Change Control, Training, Complaints, Document Control).
• Skills: Strong attention to detail and organizational skills, ability to work independently, competence with Microsoft Office (Excel, Word, Visio); LIMS or data tracking systems a plus, comfort performing tasks in a cleanroom setting and wearing PPE for extended periods, strong written and verbal communication skills, hands-on experience with electronic QMS, particularly MasterControl (system administration and process ownership), hand-on experience with LIMS or sample management programs, ability to lift up to 30 pounds and maintain good hand-eye coordination, and ability to bend, lift, and squat.

ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.