"Alerted.org

Job Title: QC Analytical Supervisor

Type: Contract-to-Hire

Hours: 2nd shift, 2:30 PM – 11:00 PM

Pay Rate: $50–$58 per hour (Depending upon experience)

Be part of a growing, innovative team in cell and gene therapy, with opportunities to lead, mentor, and shape QC operations!

Summary

Lead and manage a QC Analytical team supporting cell and gene therapy. Oversee day-to-day lab operations, ensure cGMP compliance, maintain audit readiness, and manage staff performance. Hands-on with CBC, Endotoxin, ELISA, qPCR, and quality records.

Responsibilities

+ Supervise, coach, and develop QC staff

+ Approve investigations and OOS documentation

+ Maintain compliance with FDA/EU regulations

+ Drive process improvements and KPI achievement

+ Oversee projects, workflow, and cross-functional initiatives

+ Ensure accurate QC data review and Certificates of Analysis

Requirements

+ Bachelor’s degree in science or relevant field

+ Minimum of 7+ years of experience with analytical laboratory, QC experience, biopharmaceutical industry, cell and/or gene therapy or equivalent

+ Strong knowledge of FDA and EU regulatory standards. cGMP experience required.

+ Strong knowledge of analytical test methods and philosophies.

+ Hands on experience with assays such as flow cytometry, ELISA, Endotoxin, CBC, cell count.

+ Strong knowledge of quality systems and ability to interpret Quality standards of implementation and review.

+ Proficient with computer software with MS Office, iStability and LIMS.

+ Excellent communication, leadership, and project management skills

Benefits

System One, and its subsidiaries including Joulé, ALTA IT Services, and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

#M3

Ref: #558-Scientific

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.