QC Sample Management Associate

Responsibilities

Sample Receipt, Registration & Chain of Custody 
• Receive incoming manufacturing, release, stability, in-process, raw material, reference, and externally supplied 
  samples as applicable; verify material information, quantities, labeling, packaging condition, and complete 
  required documentation. 
• Document sample receipt, transfers, custody handoffs, locations, status changes, and final disposition in logs, 
  or tracking systems; investigate and escalate discrepancies promptly. 
• Maintain end-to-end traceability and sample segregation to prevent mix-ups, unauthorized access, loss, or 
  inappropriate use.
 
Sample Setdowns, Distribution & Inventory 
• Coordinate product sample setdowns, including receipt from Manufacturing, reconciliation against sampling 
  plans, labeling, staging, controlled storage, and timely distribution to assigned QC or stability testing groups. 
• Maintain accurate inventories of product samples, retains, reference materials, critical reagents, and other 
  controlled laboratory materials, including quantities, locations, expiration/retest dates, and storage 
  requirements. 
• Support sample pulls, stability timepoint staging, sample reconciliation, reserve/retain management, approved 
  returns, and documented disposition or destruction. 
• Monitor refrigerator, freezer, and ambient storage capacity; review alarm records as assigned and promptly 
  escalate temperature excursions or equipment issues. 

Outsourced Testing & Shipping Logistics 
• Coordinate sample submissions to approved contract testing laboratories, including sample selection, 
  reconciliation, required submission forms, testing instructions, and supporting documentation. 
• Prepare and track domestic and, when applicable, international shipments using qualified packaging and 
  temperature controls; coordinate with approved shipping personnel for dry ice, biological, hazardous, or other 
  regulated shipments. 
• Confirm shipment dispatch, delivery, receipt acknowledgment, and sample condition; follow up on delays, 
  missing shipments, discrepancies, and return shipments. 
• Maintain accurate shipment records, courier tracking, chain-of-custody evidence, and external laboratory 
  correspondence. 

GMP Compliance & Operational Support 
• Perform all activities according to approved SOPs, cGMP principles, good documentation practices, data integrity 
  requirements, and site EHS standards. 
• Support deviation investigations, temperature excursion assessments, corrective actions, audits, and 
  continuous improvement related to sample handling and traceability. 
• Coordinate daily priorities with QC, Stability, Manufacturing, QA, and external partners to protect testing 
  turnaround times and scheduled stability pulls. 
• Maintain orderly sample storage and work areas; monitor supplies, shipping materials, labels, and inventory 
  consumables. 
• Identify process bottlenecks and help establish standardized workflows, tracking tools, and sample management 
  metrics. 

Qualifications

• High school diploma or equivalent with 2+ years of relevant pharmaceutical, biotechnology, GMP laboratory, 
  sample logistics, or regulated inventory experience; OR associate degree in a relevant discipline with 1+ year of 
  related experience; OR relevant bachelor’s degree with demonstrated laboratory/sample logistics exposure.
• Ability to accurately follow SOPs, maintain contemporaneous documentation, and manage multiple time
  sensitive sample requests. 
• Familiarity with chain of custody, sample identification, inventory reconciliation, controlled storage, and shipping 
  documentation. 
• Comfort using Microsoft Excel, Outlook, and electronic tracking systems; ability to learn LIMS, ERP, or electronic 
  quality systems. 
• Strong organization, attention to detail, communication, and willingness to escalate quality or integrity concerns.
 
Preferred Qualifications 
• 2–4 years of direct QC sample management experience in a GMP biopharmaceutical, CDMO, or regulated testing 
  laboratory. 
• Experience coordinating stability samples, product setdowns, contract laboratory submissions, and cold-chain 
  shipments. 
• Working knowledge of LIMS, GMP documentation, deviation workflows, and temperature-controlled inventory 
  systems. 
• Training or qualification in dangerous goods or dry ice shipping, where relevant to assigned duties.