QC Analyst Contractor

ProKidney•Winston-Salem, NC

About The Position

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.

Requirements

Bachelor's degree (BS) in Microbiology, Biology, Chemistry, or equivalent.
Minimum 3-5 years of relevant experience.
Knowledge of cGMP requirements, Good Laboratory Practices (GLP), Good Documentation Practices (GDP), SOPs, QC schedules, and applicable safety policies and procedures.
Ability to exercise judgment within defined procedures and practices.
Ability to read, understand, and follow QC schedules and SOPs.
Ability to work independently and collaboratively.
Ability to use Microsoft Office.
Ability to maintain organized records.
Ability to manage time effectively.
Ability to demonstrate good eye/hand coordination.
Ability to communicate effectively in writing and verbally.
Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.

Nice To Haves

Preferred area of study: science-related discipline.

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.