Quality Assurance Specialist II MRB

Overview

Iovance Biotherapeutics is a global leader in innovating developing and delivering 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.

We are a patientcentric collaborative organization that is driven to change the way cancer is treated. We are agile in our thinking and strive for excellence and innovation while acting with high integrity to create value for all stakeholders.

The Quality Assurance Specialist II MRB will play a key role in the compilation of information and documentation required to release materials and products. S/he will work collaboratively to assemble information review of documentation and support releasing of materials and products. The Quality Assurance Specialist MRB will support review of deviations investigations and release of finished products. The Specialist will also ensure compliance to Iovance procedures by supporting lot closure. Quality Assurance Specialist.

Shifts available:

Sunday to Wednesday from 9AM 8PM

Wednesday to Saturday from 9AM 8PM

Specific Responsibilities

• Support preparation of information and management of attendees and distribution of the Material Review Board meeting for internally and externally manufactured Drug Product lots.
• Coordinating with Quality Systems for investigations related to product complaints and BDPR related to internally manufactured Drug Product lots.
• Coordinating deviation and investigation reviews to support release of final product and materials.
• Supporting release tasks as assigned to the Quality Release team by the schedule.
• Supporting lot release with cross functional teams for clinical release.
• Ensure compliance to cGMPs and facility procedures. Interface with functional groups such as Manufacturing Quality Control and Document Control to determine events (errors deficiencies discrepancies deviations and other observations) and report to management.
• Update review and maintain documentation related to quality assurance activities.
• Review batch records and related production documentation ensuring resolution of all identified issues prior product disposition.
• Collaborate with internal functions to address all identified issues in a timely manner. Determine if the issue needs to be documented in the Quality System.
• Reports errors deficiencies discrepancies and observations to management that could impact product Quality on release.
• Perform disposition finished product.
• Support generation of Quality Metrics.
• Perform miscellaneous duties as assigned.

Education and Qualifications

• A Bachelors Degree in Science Engineering or a related technical discipline.
• At least 35 years of experience in a regulated industry.
• Proficient knowledge of cGMP regulations.
• Perform routine activities with minimal oversights.
• Prior experience with review of Manufacturing and/or QC data specific to cell therapy testing preferred.
• Strong administrative skills including use of Microsoft Word Excel and PowerPoint.
• Must be skilled in planning and organizing decisionmaking and building relationships
• Able to effectively work in a dynamic / fastpaced environment
• Extremely detail oriented with strong technical skills.
• Knowledge of MasterControl is preferred.
• High level of accountability and ownership.
• Demonstrate a sense of urgency and ability to recognize time sensitivity.
• Ability to effectively manage multiple priorities involving aggressive timelines at a high level of productivity.
• Successfully interface with multidisciplined teams.

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 andexert 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 problemsolving analysis and discretion; ability to handle workrelated 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 equalopportunity employer our employees and applicants will be considered without regard to an individuals 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 .

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 ourCandidate Privacy Notice.

#LIonsite