QC Sample Management Technician, 2nd Shift

Position Summary

The QC Sample Management Technician is a member of the Quality Control organization and is responsible for the end-to-end lifecycle management of QC samples in a GMP-regulated environment. This role ensures accurate receipt, labeling, storage, tracking, distribution, reconciliation, and disposition of samples supporting raw materials, in-process materials, finished product, utilities, and stability programs.

The QC Sample Management Technician plays a critical role in maintaining data integrity, inspection readiness, and efficient laboratory operations by ensuring samples are handled in accordance with approved procedures, regulatory expectations, and site quality standards.

• Receive, inspect, and log QC samples from manufacturing, stability, utilities, and external sources in accordance with approved SOPs.
• Routinely monitor, and facilitate, transfer of samples from the clean rooms to their respective destinations (QC, Supply Chain, QA, etc.).
• Verify sample integrity, labeling accuracy, chain of custody, and required documentation prior to accessioning.
• Assign and apply compliant sample labels, ensuring traceability throughout the sample lifecycle.

• Manage sample storage in controlled environments (e.g., ambient, refrigerated, frozen, stability chambers), ensuring conditions are maintained and monitored.
• Maintain accurate real-time inventory of all QC samples using approved tracking systems (e.g., LIMS, ERP, or manual logs).
• Perform routine inventory counts and reconcile discrepancies in accordance with procedures.
• Maintain inventory of cross functional consumables.

• Coordinate sample distribution to QC Chemistry, QC Microbiology, and external testing laboratories as required.
• Ensure samples are transferred, shipped, or staged in compliance with internal procedures, safety requirements, and regulatory expectations.
• Communicate sample status, priorities, and issues to QC analysts, supervisors, and QC Technical Services as needed.

• Manage sample retention programs, including stability pulls, reserve sample storage, and sample destruction activities.
• Execute sample disposition activities (e.g., destruction, return, archiving) in alignment with approved SOPs and environmental, health, and safety requirements.
• Ensure complete and accurate documentation of sample disposition activities to maintain inspection readiness.

• Generate, review, and maintain GMP documentation related to sample management activities (logs, forms, labels, inventory records).
• Adhere to Good Manufacturing Practices (GMP), data integrity principles, and site quality policies at all times.
• Support audits, inspections, and internal quality reviews by providing sample traceability and documentation.

• Support general QC laboratory operations, including organization of sample areas, housekeeping, and supply management related to sample handling.
• Participate in investigations, deviations, CAPAs, or change controls related to sample management activities, as assigned.
• Contribute to continuous improvement initiatives aimed at improving efficiency, compliance, and reliability of sample management processes.

• Demonstrates team‑oriented behaviors and a willingness to support cross‑functional QC activities as needed.
• Communicates clearly and professionally with QC analysts, QC leadership, manufacturing, and support functions.
• Maintains a strong quality mindset, attention to detail, and sense of ownership for assigned responsibilities.

• Associate degree in a scientific or technical discipline with 5 years’ experience, Bachelors degree in a technical discipline.
• Prior experience working in a GMP-regulated environment, laboratory, manufacturing, or quality organization preferred.
• Strong organizational skills with the ability to manage multiple priorities and maintain accurate records.
• Proficiency with electronic systems (e.g., LIMS, ERP, spreadsheets, databases)…