Quality Agents, LLC is a service company offering laboratory and quality expertise to the pharmaceutical and biotechnology industries. Our Lab Technicians are placed at client sites to support biocentre and research sample management operations. This individual will work on-site in Gaithersburg, Maryland, supporting the accurate, timely, and compliant receipt, storage, and dispatch of biological specimens and materials. The Lab Technician will handle temperature-sensitive biological products, maintain rigorous documentation, and support the client's commitment to quality and regulatory standards including GxP and ISO 20387.
Responsibilities include:
Receive incoming biological specimens; verify chain-of-custody, documentation, subject IDs, and consent flags; reconcile discrepancies and escalate issues as appropriate.
Accession samples into the Laboratory Information Management System (LIMS); apply barcodes and labeling standards; ensure accurate metadata capture including matrix, volume, aliquots, collection date/time, and freeze-thaw count.
Place samples in appropriate temperature-controlled storage (ambient, 4 degrees C, -20 degrees C, -80 degrees C, LN2) per stability profiles; maintain accurate location mapping and inventory counts; conduct regular reconciliations.
Pick, pack, and ship samples to internal labs and external partners; prepare documentation, temperature loggers, and manifests; ensure compliance with IATA and UN3373 requirements.
Follow GxP and ISO 20387 standards and biobank SOPs; participate in internal audits, CAPAs, and continuous improvement activities; maintain current training records.
Monitor freezers and LN2 tanks; respond to alarms; perform daily/weekly checks and preventive maintenance tasks; document corrective actions.
Maintain complete audit trails; ensure data accuracy, version control, and secure handling of sensitive information.
Adhere to applicable Biosafety Level requirements; use PPE; manage spill response and waste disposal; support risk assessments and incident reporting.
Author and update SOPs, job aids, and work instructions; generate inventory and KPI reports including accession turnaround time, error rates, and retrieval accuracy.
Interface with clinical operations, study teams, laboratory staff, and external vendors to facilitate sample-related activities.
Skill Level and Requirements:
Strong attention to detail, organizational skills, and accurate record-keeping ability.
Comfortable handling temperature-sensitive, perishable, and potentially infectious biological materials.
Ability to work efficiently in a fast-paced, team-oriented environment.
Basic computer literacy and experience with inventory management systems or LIMS.
Good verbal and written communication skills.
Familiarity with regulations for transporting biological materials (IATA, DOT, UN) is highly desirable.
Minimum Requirements:
High school diploma or equivalent required; additional education or training in laboratory sciences, logistics, or life sciences preferred.
Previous experience in logistics, shipping/receiving, or handling of biological materials in a biobank, clinical laboratory, biomedical, or related setting.
Current driver's license and auto insurance.
Quality Agents offers a full suite of benefits for full-time employees including:
Health, dental and vision insurance
Life, AD&D and disability Insurance
Health savings account for participants in our health plan
401k retirement plan
Paid time off
Paid holidays
Quality Agents accepts applications on an on-going basis in order to build a talent pool of potential candidates. These applications remain open for consideration, as positions become available, for one (1) year from the date of application. After that time, or if your application information changes, please submit your application again.
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