Laboratory Associate
2 days ago
Edison
Job DescriptionJob Title: Quality Assurance Associate – Aseptic Clean Room Technician Job 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. Responsibilities • 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.Essential Skills, • 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).Additional Skills & Qualifications, • 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.Work Environment 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. Job Type & Location 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 This is a fully onsite position in EDISON,NJ. Application Deadline This position is anticipated to close on Jul 16, 2026. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options. San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records. Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.