With extensive experience in developing biologics and bioconjugates, we offer a seamless service delivered by fully integrated teams, from early discovery to commercial manufacturing.
Forward-thinking and committed, we find the best solution and use the right technologies to design, develop and manufacture your products to ensure we get vital medicines to patients quickly and safely.
We are dedicated to quality excellence. We are driven to get better treatments to market, efficiently and responsibly by reducing timelines and delivering the highest quality products and services.
We are Abzena. More than a CDMO, we are a responsible and dedicated partner that takes care of your products from concept to patient.
The QC Sample Management Specialist coordinates the end-to-end movement, traceability, storage, and disposition of GMP and non-GMP laboratory samples supporting analytical testing, stability programs, manufacturing, and outsourced testing. This role serves as a critical operational interface among QC, Manufacturing, Stability, Supply Chain, Quality Assurance, and external testing laboratories. The specialist ensures samples are accurately received, logged, staged, transferred, shipped, reconciled, and maintained under appropriate conditions while protecting chain of custody, data integrity, and testing timelines.
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.
• 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.
Abzena is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.
This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, and training.