Lead QC Sample Management, Cell Therapy

Who We Are

RoslinCT is a world-leading cell and gene therapy contract development and manufacturing organization creating cutting‑edge therapies that change people’s lives. Collaborative, dedicated, and talented people are the backbone of our culture, working both autonomously and in driven teams to make life‑changing products utilizing ground‑breaking science.

RoslinCT is a world-leading cell and gene therapy contract development and manufacturing organization creating cutting‑edge therapies that change people’s lives. Collaborative, dedicated, and talented people are the backbone of our culture, working both autonomously and in driven teams to make life‑changing products utilizing ground‑breaking science.

Here at RoslinCT, our team can contribute to the development of revolutionary treatments. We live every day by our core values:
Partner Focus, One Team, Personal Growth, Integrity, Innovation, and Trust and Respect. We put our employees at the forefront by providing a flexible and empowering work environment, an attractive benefits package, and an emphasis on work‑life balance. Our people are the key to our success. At RoslinCT we focus on developing our corporate culture, people’s development, growth, and the ability to impact patients.

The Quality Control Sample Management Lead will be responsible for working under guidance of a QC Manager and He/she Will support the receipt, delivery, shipping and disposal of in-process, release, raw material samples for QC testing for cell therapy products in compliance with all applicable quality systems and current cGMPs. He/she may also support routine QC laboratory and testing activities as needed.

• Serve as the QC Sample Management lead and gatekeeper for in-process, release, raw material, retain, and stability samples, ensuring samples are received, triaged, stored, transferred, shipped, and disposed of in accordance with approved procedures, quality systems, and current cGMP requirements.
• Coordinate sample collection, testing schedules, and delivery priorities with Manufacturing, QC laboratories, Quality Assurance, Program Management, and external testing partners to support timely testing and product disposition.
• Verify sample submissions, required documentation, labeling, chain of custody, and sample condition at receipt; elevate discrepancies, delays, or compliance risks promptly.
• Maintain accurate sample inventory and transaction records, including quarantine, released, retain, stability, and testing material inventories using applicable spreadsheets, laboratory notebooks, LIMS, or other approved tracking systems.
• Ensure appropriate sample handling, storage conditions, cold chain transfers, retention, reconciliation, and disposal practices to preserve sample integrity and traceability throughout the sample lifecycle.
• Act as the primary liaison with external contract testing laboratories, supporting quote requests, sample shipment coordination, testing timelines, result tracking, certificates of analysis, and issue resolution.
• Generate, maintain, and communicate QC sample management metrics to monitor workload, turnaround times, inventory status, right‑first‑time documentation, and process performance.
• Support investigations, deviations, change controls, CAPAs, audits, and inspection readiness activities related to QC sample management, raw materials, sample documentation, and laboratory operations.
• Write, revise, and review QC sample management procedures, sample handling instructions, material specifications, testing documentation, protocols, and reports as needed.
• Support routine and non‑routine QC laboratory activities or analytical testing for in-process, raw material, final product, or stability samples as needed to meet business and project needs.
• Support analytical equipment installation, qualification, and compliant data practices, including 21 CFR Part 11 expectations, as applicable.
• Identify and implement opportunities to improve sample flow, inventory accuracy, documentation quality, communication, and overall QC sample management efficiency.
• Collaborate…