Lead QC Sample Management, Cell Therapy

RoslinCT US•Hopkinton, MA

9d•$85,000 - $125,000•Onsite

About The Position

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.

Requirements

Bachelor’s degree in a scientific discipline, such as Biology, Chemistry, Biochemistry, Microbiology, Biotechnology, or a related field; equivalent relevant experience may be considered.
5+ years of experience in a GMP-regulated Quality Control, laboratory operations, sample management, manufacturing support, or related biotech/pharmaceutical environment.
Prior experience leading, coordinating, or serving as a subject matter expert for QC sample management activities, including sample receipt, triage, storage, transfer, shipment, inventory, reconciliation, and disposal.
Strong understanding of cGMP requirements, quality systems, data integrity expectations, Good Documentation Practices, and regulatory expectations for sample handling, traceability, chain of custody, and laboratory records.
Experience using LIMS, electronic quality systems, inventory tracking tools, laboratory notebooks, Microsoft Excel, and other systems used to document and track sample transactions.
Demonstrated ability to manage competing priorities, coordinate sample testing timelines, communicate risks, and drive follow-through in a fast-paced manufacturing or laboratory environment.
Experience partnering with Manufacturing, Quality Assurance, QC laboratories, Program Management, Supply Chain, and external contract testing laboratories to support timely sample testing and product disposition.
Excellent attention to detail, organization, written and verbal communication, problem-solving, teamwork, and stakeholder management skills.
Ability to work independently, lead by influence, support team members, escalate issues appropriately, and maintain compliance while meeting business-critical timelines.

Nice To Haves

Knowledge of cold chain handling, controlled-temperature storage, biological sample integrity, retention requirements, stability samples, and external sample shipment practices is preferred.
Experience supporting deviations, investigations, CAPAs, change controls, audit readiness, inspection readiness, SOP revisions, protocols, reports, and other GMP documentation is preferred.
Familiarity with cell therapy, gene therapy, biologics, aseptic manufacturing, raw materials, in-process testing, release testing, retain samples, and/or stability programs is strongly preferred.
Working knowledge of analytical methods and compendial or routine QC testing such as pH, osmolality/osmolarity, appearance, identity testing, qPCR, flow cytometry, ELISA, cell-based assays, or microbiological testing is a plus.

Responsibilities

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; escalate 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 cross-functionally and model RoslinCT values by maintaining a high level of organization, attention to detail, compliance awareness, urgency, and partnership with internal and external stakeholders.
Perform other duties as assigned.