Quality Assurance Associate - Aseptic Clean Room Technician

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, NJOn-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, NYOn-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

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.

This is a Contract position based out of EDISON, NJ. Pay and Benefits

The pay range for this position is $16.00 - $19.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

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

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