QC Analyst Contractor

United States·Winston-Salemmid

OtherQc Analyst

0 views0 saves0 applied

Apply Now

Quick Summary

Key Responsibilities

Participates in routine environmental monitoring of the Cell Processing Units (CPUs), facility, and cleanroom equipment. Reads, understands, and follows Standard Operating Procedures (SOPs).

Requirements Summary

Participates in routine environmental monitoring of the Cell Processing Units (CPUs), facility, and cleanroom equipment. Reads, understands, and follows Standard Operating Procedures (SOPs).

Technical Tools

OtherQc Analyst

Responsibilities

~2 min read

→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.

Requirements

~1 min read

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.

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.

Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.