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Supervisor, Quality Assurance Logistics

2 months ago

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

We are seeking a highly skilled Logistics Supervisor, Quality Control to join our team at Iovance Biotherapeutics Inc. This is a critical role that requires strong leadership and organizational skills to manage the quality control logistics function.

Key Responsibilities
  • Supervise and Develop Direct Reports: Lead a team of operators, providing guidance, coaching, and mentoring to ensure they have the skills and knowledge to perform their duties effectively.
  • Schedule and Coordinate Activities: Plan and coordinate daily activities to ensure conformance to the schedule and adherence to quality control procedures.
  • Review Batch Documentation: Verify the completeness and accuracy of batch documentation and logbooks.
  • Author and Revise Documentation: Develop and revise standard operating procedures (SOPs), sample plans, deviations, and corrective action plans (CAPAs) to ensure compliance with regulatory requirements.
  • Establish Objectives and Conduct Performance Reviews: Set goals and objectives for direct reports, monitor progress, and provide timely feedback to management.
  • Manage QC Sample Management: Oversee the storage, inventory, and shipping of quality control samples, ensuring compliance with procedures and regulatory requirements.
  • Maintain Sample Integrity: Ensure that all samples are handled, stored, and shipped in accordance with procedures and regulatory requirements.
  • Optimize Team Performance: Supervise and train the iCTC QC logistics team to ensure optimal performance and compliance with regulatory requirements.
  • Ensure Vendor Compliance: Monitor and ensure that vendors meet quality control and regulatory requirements.
  • Distribute Samples: Coordinate the timely distribution of samples internally and externally to testing vendors.
  • Maintain Inventory Records: Ensure that sample inventory records are accurate and up-to-date.
  • Develop and Improve Procedures: Create and revise procedures to ensure compliance with regulatory requirements and optimize logistics operations.
  • Stay Current with Regulations: Maintain knowledge of regulatory requirements, industry best practices, and company policies to ensure compliance and optimize logistics operations.
  • Support Audits and Inspections: Participate in audits and inspections as required to ensure compliance with regulatory requirements.
Requirements
  • Education and Experience: Associate's degree or at least 5 years of relevant cGMP experience.
  • Leadership Experience: Proven experience in supervising a team with direct reports.
  • Inventory and Logistics Experience: Experience with inventory and logistics in the pharmaceutical industry.
  • Quality Mindset: Familiarity with 21 CFR Part 11 and standard GxP best practices and FDA regulations.
  • Hands-on Laboratory Experience: Experience with sample handling, inventory, and cryo-shipping.
  • Collaboration and Communication Skills: Strong collaboration, time management, and organizational skills, with excellent written and verbal communication skills.
  • Problem-Solving and Analytical Skills: Proactive, results-oriented, self-starter with demonstrated strong leadership skills and experience in a complex manufacturing environment.
  • Attention to Detail: Detail-oriented with strong mathematical skills.
  • Adaptability and Flexibility: Ability to work successfully in a fast-paced team-oriented environment.
  • Physical Demands: Must be able to wear cleanroom attire and PPE, stand and/or walk 90% of the scheduled workday, and lift and carry objects weighing 45 pounds.