QC Associate I

Overview

Perform QC testing, flow cytometry, cell culture, and documentation for cell therapies.

Key Responsibilities

• cell culture
• flow cytometry
• method validation
• equipment maintenance
• data upload
• capa

Tasks

-Investigate out-of-specification, out-of-trend, or non-conforming test results. -Conduct cell culture and cell counting for quality control purposes. -Document and report results following company and client procedures and guidelines. -Provide training and oversight to new team members. -Assist in training other Quality Control technicians. -Participate in equipment and method qualification/validation activities. -Assist in analysis for flow methods and complexity testing. -Implement corrective and preventive actions as applicable. -Execute company and client test methods and procedures for cellular products. -Communicate effectively with coworkers, departments, management, and clients. -Upload data in real-time to shared drives or client SharePoint sites. -Maintain, monitor, and troubleshoot laboratory equipment. -Initiate and prepare deviation reports with supervisory input. -Respond to equipment alarms using the Linc Alarm Report system. -Prepare reagents and media as needed. -Perform testing to develop methods for flow cytometry and analysis. -Cross-train in methods for multiple clients to enhance lab efficiency. -Complete documentation according to SOPs, CGMP, and GDP. -Organize laboratory supplies and perform equipment cleaning as per SOP.

Requirements

• cgmp
• visio
• flow cytometry
• pcr
• quality control
• bachelor's

What You Bring

-Experience in a CGMP/GTP environment. -Proficiency with computer software such as Microsoft Office and Visio. -Experience with test methodology within a quality control setting. -1-2 years of experience in performing flow cytometry assays and endotoxin testing. -Experience in clinical laboratories, microbiology, hematology, blood banking, or immunology. -Proficiency in aseptic techniques, assay, and document control. -Experience in training and leading others in a laboratory setting. -Experience in tissue culture, bioburden, PCR, and quantitative analysis. -Bachelor's or master's degree in a related scientific field. -Experience in microbiology test methods and use of necessary equipment. -1-2 years of cell culture experience. -Minimum 2-4 years of experience in a Quality Control laboratory setting or within the biopharmaceutical industry. -Prior industrial experience in cell count methodologies and cell therapeutic experience.

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Benefits

-Employee Assistance Program -Short and long-term disability -Time Off/Leave (PTO, Vacation or Sick Leave) -Medical, dental & vision -Life Insurance (Voluntary Life & AD&D for the employee and dependents) -Critical Illness, Accident, and Hospital -Health Spending Account (HSA) -Transportation benefits -401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available

About Actalent

-Born in July 2021 by merging Aerotek’s engineering & sciences arm with EASi, Actalent emerged as a focused engineering-and-science partner. -Backed by Allegis Group, it drives scale and speed to market via contract, managed, and technical services. -Headquartered in Maryland with global reach, it deploys specialized teams across North America, Europe, and APAC on Fortune 500 projects. -Typical engagements span EV design, vaccine development, lab services, clinical research, and infrastructure systems. -Expertise covers a wide spectrum: aerospace, defense, healthcare, manufacturing, software systems, environmental and civil engineering.

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