Overview

The Quality Assurance Compliance Intern will support the Compliance team through documentation review, data mining, and communication associated with suppliers and internal stakeholders. As part of this role the intern will gain an understanding of Quality within Cell Therapy manufacturing in a clinical and commercial setting. This will include regulations and guidelines as they apply to GMP and GxP manufacturing.

Essential Functions and Responsibilities

• Supplier Scorecard
  • Support the design and implementation of the scorecard process and be responsible for communication with vendors and internal stakeholders.
• Audit Support
  • Collaborate with internal stakeholders in support of materials and services procured for audit preparations.
  • Tracking completed and upcoming inspections using audit log.
  • Negotiate audit dates with vendors as per the audit schedule.
  • Schedule and attend pre-audit business meetings with Iovance stakeholders.
• Quality Agreements
  • Accurately track in-process Quality Agreements.
  • Review in-process quality agreements for editorial/administrative changes.
• Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
• Perform miscellaneous related duties as assigned

Required Education, Skills, and Knowledge

• In-process higher level education in a scientific discipline.
• No certifications required.
• Proficient in Microsoft Office (Excel, Word, PPT, Visio).
• Strong ability to communicate effectively and concisely.
• Works well under pressure and meets tight deadlines.
• Fantastic organizational, time management skills and attention to detail
• Able to work independently
• Ability to effectively learn and acquire new knowledge and skills
• Able to share knowledge and work in a strong team-oriented environment

The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation.

Physical Demands and Activities Required (This would need to be adjusted by HRBP depending on the position and needs using the assessment form)

• Must be able to remain in a stationary position standing or sitting for prolonged periods of time.
• Must be able to move about inside an office and exert up to 10 pounds of force occasionally or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects.
• Must have visual acuity to perform activities such as: preparing and analyzing data and figures, viewing a computer screen, and extensive reading.
• This position requires repetitive motion, substantial movements (motions) of the wrist, hands, and/or fingers.
• Must be able to communicate with others to exchange information.

Mental: Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines

Work Environment

This job operates in a professional or remote office environment and requires operating standard office equipment and keyboards.

The statements contained in this document are intended to describe the general nature and level of work being performed by a colleague assigned to this description. They are not intended to constitute a comprehensive list of functions, duties, or local variances. Management retains the discretion to add or to change the duties of the position at any time.

Iovance is committed to cultivating and offering a diverse and inclusive work environment. As an equal-opportunity employer, our employees and applicants will be considered without regard to an individual’s 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, and any other characteristic protected by applicable law. If you need assistance or accommodation to apply to one of our opportunities, please contact careers@iovance.com.

By voluntarily providing information and clicking “Submit Application”, you explicitly consent to the collection and use of your personal information for the purposes described above and in our Candidate Privacy Notice. 

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