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.
Essential Job Functions
Sample Receipt and Accessioning
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Receive, inspect, and log QC samples from manufacturing, stability, utilities, and external sources in accordance with approved SOPs.
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Routinely monitor, and facilitate, transfer of samples from the clean rooms to their respective destinations (QC, Supply Chain, QA, etc.).
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Verify sample integrity, labeling accuracy, chain of custody, and required documentation prior to accessioning.
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Assign and apply compliant sample labels, ensuring traceability throughout the sample lifecycle.
Sample Storage and Inventory Control
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Manage sample storage in controlled environments (e.g., ambient, refrigerated, frozen, stability chambers), ensuring conditions are maintained and monitored.
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Maintain accurate real‑time inventory of all QC samples using approved tracking systems (e.g., LIMS, ERP, or manual logs).
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Perform routine inventory counts and reconcile discrepancies in accordance with procedures.
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Maintain inventory of cross functional consumables.
Sample Distribution and Coordination
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Coordinate sample distribution to QC Chemistry, QC Microbiology, and external testing laboratories as required.
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Ensure samples are transferred, shipped, or staged in compliance with internal procedures, safety requirements, and regulatory expectations.
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Communicate sample status, priorities, and issues to QC analysts, supervisors, and QC Technical Services as needed.
Sample Retention and Disposition
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Manage sample retention programs, including stability pulls, reserve sample storage, and sample destruction activities.
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Execute sample disposition activities (e.g., destruction, return, archiving) in alignment with approved SOPs and environmental, health, and safety requirements.
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Ensure complete and accurate documentation of sample disposition activities to maintain inspection readiness.
Documentation and Compliance
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Generate, review, and maintain GMP documentation related to sample management activities (logs, forms, labels, inventory records).
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Adhere to Good Manufacturing Practices (GMP), data integrity principles, and site quality policies at all times.
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Support audits, inspections, and internal quality reviews by providing sample traceability and documentation.
Laboratory and Operational Support
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Support general QC laboratory operations, including organization of sample areas, housekeeping, and supply management related to sample handling.
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Participate in investigations, deviations, CAPAs, or change controls related to sample management activities, as assigned.
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Contribute to continuous improvement initiatives aimed at improving efficiency, compliance, and reliability of sample management processes.
Interpersonal and Team Focus
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Demonstrates team‑oriented behaviors and a willingness to support cross‑functional QC activities as needed.
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Communicates clearly and professionally with QC analysts, QC leadership, manufacturing, and support functions.
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Maintains a strong quality mindset, attention to detail, and sense of ownership for assigned responsibilities.
Qualifications
Required
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Associate degree in a scientific or technical discipline with 5 years’ experience, Bachelors degree in a technical discipline.
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Prior experience working in a GMP-regulated environment, laboratory, manufacturing, or quality organization preferred.
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Strong organizational skills with the ability to manage multiple priorities and maintain accurate records.
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Proficiency with electronic systems (e.g., LIMS, ERP, spreadsheets, databases) and written documentation.
Preferred
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Experience with QC sample management, stability programs, or laboratory logistics.
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Familiarity with GMP documentation practices, data integrity principles, and regulatory expectations (e.g., FDA, EMA).
Physical and Work Environment Requirements
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Ability to work in laboratory and warehouse environments, including lifting, carrying, and moving sample containers as required.
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Ability to wear required personal protective equipment (PPE) and work in controlled temperature environments.
Development and Growth
This is an entry to intermediate‑level QC role with opportunities for cross‑training and advancement within Quality Control, including exposure to QC Chemistry, QC Microbiology, and QC Technical Services functions.
Additional info about INCOG BioPharma Services:
At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business/
If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus._
INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.
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