Biobank Lab Technician: GxP, ISO 20387, Temp-Sensitive

Quality Agents; Gaithersburg (MD); On-site; USD 42,000 - 62,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

Life insurance

Disability insurance

401k plan

Paid time off

Paid holidays

Job summary

Quality Agents, LLC seeks a Lab Technician to work on-site in Gaithersburg, Maryland, supporting receipt, storage, and dispatch of biological specimens and materials. You will ensure accurate documentation, temperature-controlled handling, and regulatory compliance under GxP and ISO 20387.

Daily responsibilities include accessioning samples in LIMS, verifying chain-of-custody, managing inventories, and preparing shipments with proper temperature logs and manifests, while maintaining audit trails

Qualifications

• High school diploma or equivalent; lab sciences or logistics training preferred.
• Experience in logistics, shipping/receiving, or handling of biological materials in biobank or clinical lab.
• Current driver's license and auto insurance.

Responsibilities

• Receive incoming biological specimens; verify chain-of-custody, documentation, subject IDs, and consent flags; reconcile discrepancies and elevate issues as appropriate.
• Accession samples into LIMS; apply barcodes and labeling, capture metadata (matrix, volume, aliquots, date/time, freeze-thaw).
• Place samples in temperature-controlled storage; maintain inventory counts and location mapping; conduct reconciliations.
• Pick, pack, and ship samples; prepare documentation, temperature loggers, and manifests; ensure IATA/UN3373 compliance.
• Follow GxP and ISO 20387; participate in audits, CAPAs, and training records.
• Monitor freezers/LN2; respond to alarms; perform checks and corrective actions.
• Maintain audit trails and secure handling of sensitive information.
• Adhere to Biosafety requirements; use PPE; manage spill response and waste.
• Update SOPs, job aids, and reports; interface with study teams and vendors.

Skills

Attention to detail

Bio material handling

Team collaboration

LIMS familiarity

Communication skills

Biological transport regs

Basic computer literacy

Education

High school diploma or equivalent

Training in lab sciences or logistics preferred

Tools

LIMS

Inventory software

Job description

Quality Agents, LLC seeks a Lab Technician to work on-site in Gaithersburg, Maryland, supporting receipt, storage, and dispatch of biological specimens and materials. You will ensure accurate documentation, temperature-controlled handling, and regulatory compliance under GxP and ISO 20387.

Daily responsibilities include accessioning samples in LIMS, verifying chain-of-custody, managing inventories, and preparing shipments with proper temperature logs and manifests, while maintaining audit trails