QC Analyst Contractor
- 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.
- 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.
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