Senior Quality Assurance Specialist, Quality Systems Training

Overview

Iovance is seeking a Senior Quality Assurance Specialist, Quality Systems Training who will be responsible for supporting several Quality Systems at Iovance’s manufacturing facility in the Navy Yard, Philadelphia. The Specialist will provide support for the following quality systems: deviations, CAPAs, and change controls. The successful candidate will have a continuous improvement mindset, and will be someone who is passionate about working with others in a complex, changing, and fast-paced manufacturing environment.

Essential Functions and Responsibilities

• Support the Quality System with emphasis on the following processes: Change Control, Deviation, and CAPA
• Provide user support for MasterControl - the electronic Quality Management System (eQMS)
• Maintain the electronic Quality Management System (eQMS), MasterControl
• Run reports and conduct data analysis to support tracking of change controls, deviations, and CAPAs to ensure timely closures of records.
• Present QS metrics to stakeholders
• Facilitate meetings or host office hours to answer QS questions
• Identify opportunities to increase the efficiency and effectiveness of the eQMS
• Implement and maintain QMS procedures and work instructions
• Maintain updated knowledge and relevant assessments of the GxP landscape, regulations, and guidelines pertaining to Quality Systems
• Participate or lead process improvement projects for deviation, CAPA, and change control
• Implement training program for deviation, CAPA and Change Control record process
• Create training materials.
• Deliver training in group sessions to ensure user proficiency with deviation, CAPA, and change control process.

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 5 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 directions and changing priorities
• Strong interpersonal skills and ability to work collaboratively across functions
• Strong computer skills including MS Office (Work, Excel, PowerPoint, Ms Project).
• Experience creating and delivering training material.

Preferred Education, Skills, and Knowledge

• Bachelor’s degree in Life Sciences discipline preferred
• Experience in other areas of Quality (Quality Operations and/or Quality Systems) is a plus
• Experience as MasterControl System Administrator or MasterControl Document Control Administrator is a plus.

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 operates in a professional 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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