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# Quality Assurance Associate - Aseptic Clean Room Technician

- **Company:** CareerCircle
- **Location:** Edison, NJ, United States
- **Experience:** Starter
- **Salary:** $33,280.0 - $39,520.0
- **Contract:** Temporary contract
- **Skills:** Microsoft Word, Agile Methodology, Artificial Intelligence, Microsoft PowerPoint, System Testing
- **Published:** July 3, 2026
- **Apply:** https://www.careercircle.com/jobs/all/all/usa/nj/edison/8abdb1dc-db76-45ef-b531-63a42aac0c03

## About the Role

Research
Visionary
Innovation
Cleanrooms
Palletizing
Pallet Jacks
Air Sampling
Investigation
Water Testing
Patient Safety
Tissue Culture
System Testing
Detail Oriented
Medical Devices
Safety Assurance
Sample Collection
Quality Assurance
Bioburden Testing
Biochemical Assays
Quality Management
Aseptic Processing
Artificial Intelligence
Environmental Monitoring
Engineering Design Process
Good Manufacturing Practices
Continuous Improvement Process
Raw Material Specification Management, * 1-2 years of quality assurance experience, preferably in a laboratory, manufacturing, or regulated environment.

 * Experience or strong exposure to environmental monitoring principles and practices in clean room or controlled environments.
 * Knowledge of basic laboratory best practices, including sample collection, handling, and labeling.
 * Hands-on experience working in aseptic or clean room conditions, including proper gowning procedures and aseptic technique.
 * Ability to operate and maintain environmental sampling equipment such as air samplers, media plates, and related instruments.
 * Strong documentation skills with the ability to complete quality assurance records accurately and consistently.
 * Understanding of GMP (Good Manufacturing Practices) and quality systems as they relate to laboratory and production environments.
 * High attention to detail and the ability to perform repetitive, routine tasks with minimal error.
 * Physical ability to work in small clean rooms, fully gown up, and lift 40-50 lbs when loading samples or product onto pallet jacks.
 * High school diploma or equivalent education (HS diploma and up)., * Experience working in organizations focused on tissue, medical devices, or similar regulated healthcare products.
 * Exposure to tissue samples, tissue culture, and related testing or processing environments.
 * Familiarity with endotoxin and bioburden testing, including LAL assays and water testing.
 * Experience with viable and non-viable environmental monitoring, including air and surface sampling.
 * Comfort working with media plates, auger equipment, and other microbiological sampling tools.
 * Ability to develop or contribute to technical specifications for raw materials used in aseptic processing.
 * Strong commitment to documentation accuracy and adherence to established procedures.
 * Ability to connect with and support a mission-driven organization focused on patient safety, donor respect, and clinical quality.
 * Willingness to work flexible hours, including first shift and potential rotating weekend schedules, as well as night shift when needed.

## Description

The Quality Assurance Associate works as part of the QA team in an aseptic clean room environment, operating specialized environmental monitoring equipment, collecting and documenting samples, and supporting the safe processing of tissue and medical products. This role focuses on maintaining strict aseptic techniques, ensuring accurate documentation, and contributing to the overall quality and safety of products through careful monitoring and adherence to established procedures., * Operate critical, highly specialized air sampling equipment within a strict aseptic clean room environment, ensuring all equipment functions correctly and is appropriately calibrated.

 * Perform environmental monitoring activities, including non-viable air sampling, viable air and surface sampling, water testing, LAL (endotoxin) sampling, and nitrogen system testing in accordance with established procedures and work instructions.
 * Maintain strict aseptic technique at all times in an ISO-class aseptic clean room processing environment to prevent contamination and cross-contamination of the environment and tissue or devices.
 * Handle sampling equipment and obtain environmental samples with a high degree of dexterity while fully gowned and gloved in aseptic attire.
 * Collect viable testing samples, water and LAL samples, and nitrogen testing samples following documented procedures and quality standards.
 * Complete all required quality assurance documentation accurately, including sample records, test forms, and tracking logs, and ensure samples are packaged properly.
 * Ship collected samples to the appropriate external or internal testing laboratories in a timely manner, following all handling and shipping protocols.
 * Generate non-conformance reports when necessary, perform investigations into potential issues, recommend and direct appropriate corrective actions, and complete all related documentation.
 * Follow up on non-conformance issues to ensure they are resolved in a timely manner and in alignment with quality assurance procedures.
 * Develop technical raw material specifications for assessing and approving incoming supplies and materials used in aseptic processing and testing.
 * Support production and manufacturing activities by providing environmental monitoring data and ensuring compliance with GMP and quality standards.
 * Work collaboratively with a team of QA technicians in a fast-paced, feedback-oriented environment, contributing to continuous improvement and adherence to quality practices., The role is based in an aseptic ISO-class clean room processing facility that focuses on providing clinically sound, safe tissue and medical products. You will work on a team of approximately seven QA technicians in a fast-paced, feedback-oriented environment that emphasizes collaboration, precision, and adherence to stringent quality standards. The organization operates as a non-profit service entity with a mission-driven culture centered on doing what is right for patients, surgeons, tissue donors, and their families. Work schedules primarily include first shift hours from 8:00 a.m. to 5:00 p.m., with flexibility for weekend and rotating weekend coverage; a third shift option runs from 11:30 p.m. to 7:30 a.m. The facility requires full clean room gowning, including gloves and other aseptic attire, and work is conducted in small, controlled environments. Employees regularly handle specialized environmental monitoring equipment and may need to lift 40-50 lbs when
loading samples or product onto pallet jacks. The organization values strong relationships with recovery partners, maintains stringent quality standards, and supports the advancement of tissue transplantation science through ongoing research and development., Berkeley Heights, NJ*On-Site
HVAC
Boilers
Turbines
Management
Switchgear
Shift Work
Electronics
High Voltage
Alarm Devices
Steam Engines
Accountability
Smoke Detector
Control Systems
Water Treatment
Equipment Repair
Agile Methodology
Project Management
Facility Management
Electrical Networks
Electrical Switches
Security Consulting
Preventive Maintenance
Commercial Real Estate
Artificial Intelligence
Building Management System
Troubleshooting (Problem Solving)
Environmental Social And Corporate Governance (ESG)
+0
State and Local Government - Consultant or Senior Consultant - New York City, NY
Guidehouse
New York, NY*On-Site
Loans
Writing
Consulting
Management
Innovation
Communication
Microsoft Word
Problem Solving
Market Analysis
Public Speaking
Agenda (Meeting)
Change Management
Project Management
Strategic Planning
Program Management
Financial Modeling
Process Improvement
Operations Research
Microsoft PowerPoint
Meeting Facilitation
Operational Analysis
Technology Strategies
Organizational Strategy
Professional Networking
Ethical Standards And Conduct
+0
Scientist
Actalent
Union Beach, NJ*On-Site
Research
Chemistry
Visionary
Innovation
Collections
Scale (Map)
Food Science
Distillation
Wet Chemistry
Detail Oriented
Beverage Products
Technical Management
Laboratory Equipment
Artificial Intelligence
Engineering Design Process
Good Laboratory Practice (GLP)
Gas Chromatography Mass Spectrometry


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