Quality Assurance Specialist, Operations Improvement

2 weeks ago

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

Salary:

Company Overview

Iovance Biotherapeutics is a progressive, late-stage organization dedicated to the advancement and commercialization of innovative cancer immunotherapies. We are currently seeking a Quality Control Specialist focused on Operations Strategy, who will play a pivotal role in ensuring the long-term viability of the Lean Labs initiative within our Quality Control Department.

This position will involve identifying and promoting continuous enhancement in collaboration with various QC functional areas, as well as developing and maintaining QC workforce models to meet patient demand effectively. Additionally, the role will contribute to strategic planning for the rollout of pipeline products and projects within the QC department.

Key Responsibilities

  • Work closely with the Senior Manager of Quality Control, Operations Strategy, and other QC functions to strategically plan future initiatives, including new product introductions, laboratory capacity planning, facility transfers, and expansions.
  • Create and maintain planning tools to facilitate site growth within the quality control organization, such as headcount capacity models to support increased manufacturing capabilities and the onboarding of new quality control assays, tests, and processes.
  • Support the deployment, hypercare, change management, and ongoing maintenance of the Lean Labs implementation in Quality Control.
  • Maintain and update QC workforce models.
  • Regularly monitor and assess KPIs, metrics, heat maps, and A3s to evaluate the performance of quality functional areas.
  • Assist in developing QC's lean capabilities by providing training and coaching in problem-solving techniques using the lean toolkit.
  • Collaborate with other continuous improvement professionals to communicate needs and projects throughout the organization, achieving solutions that drive positive business outcomes.
  • Adhere to Iovance Biotherapeutics' core values, policies, procedures, and ethical standards.
  • Comply with Safety SOPs, SDS sheets, and laboratory procedures in accordance with company policy and OSHA regulations.
  • Perform additional duties as assigned.

Required Qualifications

  • Bachelor's degree in a relevant field (biological sciences or equivalent).
  • Preferred three years of experience in the biopharmaceutical sector within a cGMP Quality Control role.
  • Experience with various operational excellence concepts, including but not limited to lean labs, lean practitioner, tier governance, coaching kata, gemba walks, job instruction, Kaizen, A3 problem solving, and change management.
  • Fundamental understanding of Quality Control operational and laboratory practices, including microbiology, analytical testing, sample management, quality records, and training.
  • Advanced proficiency in MS Office applications (Word, Excel, PowerPoint, Visio).
  • Ability to effectively collaborate with multi-disciplinary teams.
  • Highly detail-oriented with strong written and verbal communication skills.
  • Capability to manage multiple priorities under tight deadlines while maintaining high productivity.
  • Advanced skills in strategic planning and implementation.
  • Demonstrated sense of urgency and ability to recognize time-sensitive tasks.
  • Flexible and adaptable approach with a willingness to tackle challenges.
  • Proactive problem solver who identifies issues and leads efforts to resolve them.

Preferred Qualifications

  • Experience with cell therapy products is advantageous.

Physical and Mental Demands

  • Must be able to sit for extended periods while working on a computer.
  • Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to manage work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines.

Work Environment

  • This position will primarily be office-based, with occasional visits to the Quality Control labs.
  • When in the lab, the individual must be able to work in a laboratory setting with various chemical and biochemical exposures.
  • Able to work in a cleanroom environment with biohazards and chemicals.
  • Potential exposure to noise, equipment hazards, and strong odors.

The information contained in this document is intended to describe the general nature and level of work performed by an employee in this role. It is not intended to be an exhaustive list of all responsibilities, duties, or local variations. Management retains the discretion to modify the duties of the position at any time.

Iovance is committed to fostering a diverse and inclusive workplace. As an equal opportunity employer, we consider all employees and applicants without regard to race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, or any other characteristic protected by applicable law.

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