Quality Systems Specialist I

1 month ago

Philadelphia, United States Iovance Biotherapeutics Inc Full time
Job DescriptionJob DescriptionSalary:

Iovance is hosting an onsite Job Fair. 


Where: Iovance Cell Therapy Center (iCTC)  

Location: 300 Rouse Blvd Philadelphia, PA 19112  

Date: Monday, June 24, 2024 

Time: 12pm to 6pm (EDT)   

What to bring: Updated resume


We are Hiring  We look forward to seeing you at the Job Fair. 


Overview

 

Iovance is seeking a Quality Systems Specialist I who has experience in Quality Systems, QA, or Compliance in Pharmaceutical and/or Biotechnology companies

This individual will be responsible for maintaining Quality Systems at Iovance’s manufacturing facility to ensure GMP compliance in accordance with country regulations and guidelines, as well as the company’s policies and procedures.

The Quality Systems Specialist I will support and oversee Quality System activities including deviations, CAPAs, and change controls. The successful candidate will be growth-oriented, have a continuous improvement mindset, and someone who is passionate about working with others in a complex, changing, and fast-paced environment.

 

Essential Functions and Responsibilities


  • Maintain the electronic Quality Management System (eQMS), with emphasis on change control, deviation, and CAPA processes
  • Provide MasterControl site administration user support
  • Run reports and conduct data analysis to support tracking of change controls, deviations, LIRs, and CAPAs to ensure timely closures of records
  • Support training activities and back-up efforts for Quality Systems processes
  • Assist functional groups to navigate Quality Systems records
  • Maintain updated knowledge and relevant assessments of the GxP landscape, regulations, and guidelines
  • Support management with other Quality Systems and Compliance related tasks

 

Required Education, Skills, and Knowledge

 

  • BA/BS or equivalent in Biological/Physical/Chemical sciences, engineering, or equivalent focus of study from an accredited university or college with 3+ years of relevant experience 
  • Current and working knowledge of Code of Federal Regulations and International Council for Harmonization Guidelines governing current Good Manufacturing Practices for Pharmaceuticals
  • Must be comfortable in a fast-paced environment with minimal direction and changing priorities
  • Strong interpersonal skills and ability to work collaboratively with colleagues cross-functionally
  • Strong computer skills including MS Office (Word, Excel, PowerPoint, MS Project)

 

Preferred Education, Skills, and Knowledge


  • Must have experience with an electronic QMS, MasterControl

 

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

 

  • 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 works in a professional office environment and a manufacturing lab setting. Potential exposure to latex, bleach, loud noise, lab equipment hazards, strong odors, and chemical/biochemical is possible.  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. 


#LI-onsite

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