Senior Quality Control Coordinator, Sample Logistics

2 weeks ago

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

Position Title: Lead Quality Control Specialist, Sample Management

Salary: Competitive

Position Summary:

The Lead Quality Control Specialist, Sample Management plays a crucial role in overseeing the management of sample inventories and coordinating the distribution of samples both internally and externally. This includes ensuring the proper storage and shipping of quality control samples under regulated conditions.

Key Responsibilities:

  • Oversee logistics for quality control samples, including raw materials, in-process, and final product samples, ensuring accurate inventory management and reconciliation.
  • Guarantee the integrity of samples by adhering to established procedures, specifications, and current Good Manufacturing Practices (cGMP).
  • Facilitate timely distribution of samples to testing vendors and internal stakeholders.
  • Maintain accurate sample inventory systems and ensure compliance with regulatory requirements.
  • Stay informed on relevant regulations, corporate policies, and industry standards to uphold compliance in logistics operations.
  • Develop and enhance procedures to optimize adherence to cGMP.
  • Support audit processes and inspections as necessary.
  • Package samples appropriately using temperature-controlled containers, cold packs, and dry ice.
  • Conduct quality control activities and perform peer reviews of documentation.
  • Uphold the core values, policies, and ethical standards of Iovance Biotherapeutics.
  • Follow safety protocols and laboratory procedures in accordance with company policies and OSHA regulations.
  • Complete required training and maintain accurate training records.
  • Ensure compliance with Good Distribution Practices (GDP) and standard operating procedures (SOPs).
  • Conduct accurate cycle counts and maintain inventory accuracy.
  • Act as a subject matter expert in sample management.
  • Provide training and knowledge transfer to new team members.
  • Lead cross-functional projects aimed at process improvement.
  • Conduct monthly level 1 audits and prepare end-of-shift reports for the team.

Qualifications:

  • Bachelor's degree or a minimum of 4 years of relevant experience in GMP and Quality Sample Management.
  • Detail-oriented with strong analytical and mathematical abilities.
  • Exceptional written and verbal communication skills.
  • Strong organizational, time management, and collaborative skills.
  • Proven ability to work effectively with diverse stakeholders.
  • Excellent judgment and problem-solving capabilities.
  • Able to thrive in a fast-paced and dynamic work environment.
  • Hands-on experience in laboratory settings, particularly in sample handling and inventory management.
  • Demonstrated leadership skills.

Preferred Qualifications:

  • Experience in inventory management or logistics within the pharmaceutical sector.

Physical and Mental Requirements:

  • Ability to remain stationary for extended periods and to move within an office environment.
  • Capable of lifting and moving objects weighing up to 10 pounds.
  • Visual acuity for data analysis and extensive reading.
  • Requires repetitive motion and substantial hand movements.
  • Effective communication skills for information exchange.

Work Environment:

  • This role is primarily office-based, with occasional visits to Quality Control laboratories.
  • Laboratory work may involve exposure to various chemicals and biological materials.
  • Must be able to work in cleanroom environments with potential biohazards.
  • Exposure to noise and equipment hazards may occur.

The responsibilities outlined in this document are intended to convey the general nature and level of work performed by employees in this position. Management reserves the right to modify duties as necessary.

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

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