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Quality Control Logistics Supervisor

2 months ago

Philadelphia, Pennsylvania, United States Iovance Biotherapeutics Inc Full time
Job Overview

Position: Supervisor, Quality Control Logistics - Sample Management

Company: Iovance Biotherapeutics Inc.

Salary: Competitive

Company Overview:

Iovance Biotherapeutics is a pioneering company in the late-stage development and commercialization of innovative cancer immunotherapies. We are currently looking for a Supervisor in Quality Control Logistics, specifically in Sample Management, to oversee the management of sample inventories and coordinate both internal and external sample distribution, ensuring compliance with storage and shipping requirements for quality control samples.

Key Responsibilities:

  • Lead and mentor a team of operators, fostering a culture of continuous improvement and operational excellence.
  • Organize and oversee daily activities to ensure adherence to established schedules.
  • Review batch documentation and logbooks for accuracy and completeness.
  • Draft and revise standard operating procedures (SOPs), Sample Plans, and other critical documentation.
  • Set performance objectives and conduct evaluations, providing constructive feedback to team members.
  • Manage all aspects of quality control sample management, including storage, inventory reconciliation, scheduling, and shipping.
  • Ensure compliance with procedures and regulations to maintain sample integrity throughout the management process.
  • Supervise and train the QC logistics team to ensure optimal performance.
  • Oversee vendor performance related to sample management.
  • Facilitate timely distribution of samples to internal teams and external testing facilities.
  • Maintain accurate sample inventory records.
  • Develop and enhance procedures to ensure compliance with current Good Manufacturing Practices (cGMP).
  • Stay informed about regulatory requirements and industry best practices to ensure compliance.
  • Assist with audits and inspections as necessary.

Qualifications:

  • Associate's degree or a minimum of 5 years of relevant experience in cGMP environments.
  • Proven experience in supervising teams with direct reports.
  • Background in inventory management or logistics within the pharmaceutical sector.
  • Strong understanding of quality standards, including 21 CFR Part 11 and GxP best practices.
  • Hands-on experience with sample handling and logistics, including cryo-shipping.
  • Excellent organizational, time management, and collaborative skills.
  • Proactive and results-driven with demonstrated leadership capabilities in complex manufacturing settings.
  • Detail-oriented with strong analytical and mathematical skills.
  • Exceptional written and verbal communication abilities.
  • Strong judgment and problem-solving skills.
  • Able to thrive in a fast-paced, team-oriented environment.
  • Willingness to work flexible hours, including weekends and holidays, as required.
  • Commitment to Iovance Biotherapeutics' core values and compliance with all policies and procedures.
  • Current knowledge of cGMP guidelines and ability to adapt sample management methods to ensure compliance.
  • Strong technical writing skills and ability to contribute to training and documentation efforts.
  • Experience in leading training and development initiatives.

Physical and Mental Requirements:

  • Ability to wear cleanroom attire and personal protective equipment (PPE).
  • Capability to stand or walk for the majority of the workday, with some lifting of objects up to 45 pounds.
  • Clear vision for close-range tasks and ability to perform repetitive motions.
  • Strong analytical and problem-solving skills to manage multiple priorities and meet deadlines.

Work Environment:

This role will involve working in both an office and a manufacturing environment, with potential exposure to various chemicals and equipment hazards.

Iovance is dedicated to fostering a diverse and inclusive workplace. We are an equal opportunity employer and consider all qualified applicants without regard to race, color, religion, sex, national origin, age, disability, marital status, sexual orientation, gender identity, or any other characteristic protected by law.