Position Summary:

The QC Analyst Contractor supports Quality Control activities including routine environmental monitoring, operation of QC equipment, QC sample handling, protocol execution, GMP documentation, data collection, inventory support, and coordination with Quality Assurance. The role follows approved SOPs, GDP, GLP, cGMP requirements, and applicable safety policies.

Essential Duties & Responsibilities:

• Participates in routine environmental monitoring of the Cell Processing Units (CPUs), facility, and cleanroom equipment.
• Reads, understands, and follows Standard Operating Procedures (SOPs).
• Sets up and operates quality control equipment, including cell counters, centrifuges, and analytical balances.
• Coordinates with Quality Assurance to retrieve QC samples from the LN2 freezer for QC release testing.
• Provides support in the training of new hires, as required.
• Revises approved documents, including SOPs, testing forms, and MS forms.
• Monitors inventory in QC laboratories and CPUs and submits requisitions to the warehouse for material procurement, as needed.
• Participates in protocol execution meetings and completes protocol execution in a timely manner.
• Performs routine transactions in the ERP system, including material requisitions and submission of purchase requisitions for outside testing laboratories.
• Completes GMP documentation, including testing forms and logbooks, in accordance with Good Documentation Practices (GDP).
• Complies with all applicable safety policies, rules, and regulations.
• Performs procedures according to written guidelines and recognizes deviations from accepted practice.
• Works within instructions and pre-established guidelines to perform job functions.
• Supports Senior QC Analysts, as required.
• Provides process development support, as needed.
• Collects and compiles data from QC testing and Environmental Monitoring activities.
• Procures dry ice for shipment of clinical samples, when required.
• Travels to other ProKidney facilities, as required.
• Performs other duties as assigned.

Minimum Qualifications:

• Education/Training:
  • Bachelor's degree (BS) in Microbiology, Biology, Chemistry, or equivalent. Preferred area of study: science-related discipline.
• Experience:
  • Minimum 3-5 years of relevant experience.
• Knowledge:
  • Knowledge of cGMP requirements, Good Laboratory Practices (GLP), Good Documentation Practices (GDP), SOPs, QC schedules, and applicable safety policies and procedures.
• Skills:
  • Ability to exercise judgment within defined procedures and practices; read, understand, and follow QC schedules and SOPs; work independently and collaboratively; use Microsoft Office; maintain organized records; manage time effectively; demonstrate good eye/hand coordination; and communicate effectively in writing and verbally.
• Certifications/Licenses:
  • None required.