Specialist I, Quality Assurance, IOVA-A QA Ops - Tuesday to Friday from 7am-5pm [Contract to Hire]

Overview

Iovance Biotherapeutics is a global leader in innovation, development, and delivery of tumor 
infiltrating lymphocyte (TIL) therapy for people with cancer. We are pioneering a 
transformational approach to treating cancer by harnessing the ability of the human immune 
system to recognize and attack diverse cancer cells in each patient.
 
Our recent launch of AMTAGVI and associated growth has led to the creation of a new position. 
The Specialist I - IOVA-A QA Ops will be a key role that ensures adequate Quality oversight for 
the manufacture and disposition of irradiated peripheral blood mononuclear cells (iPBMCs) 
manufactured in-house. The Specialist I will be a strong and action-oriented team member who 
is capable of driving projects to completion. The role will report to the Supervisor/Manager – 
IOVA-A QA Ops.
The Specialist I is responsible for day-to-day Quality Assurance Operations activities in accordance with 
cGMPs, CFRs, ICH guidelines and company policies and procedures. The Specialist I will work onsite 
alongside manufacturing and quality control personnel, helping to ensure that the highest standard of 
work is performed for Iovance’s in-house iPBMC manufacturing activities at 700 Spring Garden St, 
Philadelphia, PA., which is co-located at the American Red Cross Penn Jersey Region. This individual is 
collaborative, organized, innovative, flexible, with a strong desire to learn and take ownership and 
accountability. 
The Specialist I will support Quality Assurance lot release and disposition activities including 
process observation, batch record review, and completion of lot release documentation. The 
Specialist I supports Quality Assurance initiatives including, but not limited to, review of 
laboratory investigations and deviation investigations. The successful candidate will support 
internal teams and be able to effectively communicate bi-directionally in a complex, changing, 
and fast-paced environment.

Essential Functions and Responsibilities
Quality Assurance Operational Support: 

• Perform QA Operations activities that include review of manufacturing batch records 
and labeling/packaging operations to ensure timely release of cell therapy products.
• Support quality assurance processes, controls and batch history files for QA Operations 
and Lot Disposition
• Perform real-time, on-the-floor support for manufacturing production activities to 
ensure compliance with GMP and GDP quality initiatives, escalating issues as required.
• Track and communicate standard work completion and hurdles.
• Actively interact with Contract Manufacturing Organizations (CMO), and internal teams 
to ensure efficient and timely batch release. 
• Maintain a collaborative and professional relationship with CMOs.
• Release of raw materials and inventory. 
• Prepare and organize release documentation for approvals.
• Support internal audits and regulatory inspections.
Subject Matter Expertise: 
• Support the efficient and timely review of laboratory investigations and deviation 
investigations. 
• Initiate and participate in standard operating procedure (SOP) revisions to improve 
compliance.
• Experience with cell therapy products and/or relevant skills.

General: 
• Ability to work effectively on multiple projects simultaneously.
• Excellent oral and written communication skills
• Must possess a high level of attention to detail.
• Ability to identify and resolve quality issues with others in a proactive, diplomatic, 
flexible, and constructive manner.
• Strong computer, organizational, and compliance skills. Proficient with Microsoft Office 
Suite, Word, Excel, and PowerPoint
• Must be comfortable in a fast-paced environment with changing priorities.
• Support QA and Logistics activities for on-going projects.
• Assist with implementing GMP QA procedures
• Other duties as assigned.

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. 
• At least 2 years demonstrating proficient GMP QA/QC experience.
• Experience with use of an electronic QMS (i.e. MasterControl, Veeva)
• Familiarity with Code of Federal Regulations and International Council for 
Harmonization Guidelines governing current Good Manufacturing Practices for 
Pharmaceuticals
• Knowledge of GMP, Good Documentation Practices (GDP) and FDA quality 
systems. 

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 perform cleanroom gowning and pass gowning qualification. 
• Must meet requirements for and be able to wear a half-face respirator.
• 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 cleanroom setting. 
Potential exposure to latex, bleach, loud noise, lab equipment hazards, strong odors, and 
chemicals/biochemicals 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. 

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