Quality Assurance Engineering Specialist

Overview

The Quality Engineer will support the Quality organization in the daytoday manufacturing and oversight of all validation commissioning and other technical activities at Iovance. The Quality Assurance Engineer will work cross functionally with Facilities Engineer Process Engineer Validation Engineering Manufacturing IT and MSAT to ensure adherence to our SOPs and cGMP requirements. The Quality Engineer will collaborate on review and approve documentation including but not limited to: SOPs validation lifecycle documents quality documents (CAPAS CCRs and DRs) work orders and engineering documentation. In addition the Quality Engineer will support audit and submission activities for regulatory compliance.

This individual will support all products from clinical programs through commercial stage products. The candidate has a demonstrated ability to work and collaborate effectively with a team to achieve consistently positive results.

Essential Functions and Responsibilities

• Identifying risk developing complex mitigation strategies alternative solutions resolving issues etc. in collaboration with cross functional groups such as Manufacturing Quality Control IT Engineering and Validation
• Supporting cGMP quality improvement efforts at iCTC (Philadelphia PA) and in remote facilities such as IOVAA (Philadelphia PA) and the Tampa Labs (Tampa Bay FL).
• Provide oversight and Quality Assurance Engineering technical support as a subject matter for commissioning validation facilities and metrology and equipment and system qualifications and their reliability and compliance.
• Partner with team members across the organization to ensure compliant Validation Engineering and IT activities to support clinical and commercial manufacturing are completed and running in compliance with cGMP.
• Collaborate closely with Engineering Manufacturing IT QC and Regulatory Affairs to build an effective Validation program for the internal manufacturing facility.
• Support other Quality Assurance functions such as Document Control QA Operations and Quality Systems as needed.
• Review and approve validation lifecycle documents including Change Records Technical Deviations Exceptions CAPAs design revisions SOPs and various engineering protocols from basis of design to commissioning (SAT FAT and Turn Over Packages).
• Live the company values by example including Iovance Quality mindset principles.

Travel: Less than 10

Required Education Skills and Knowledge

• 2 years of biopharmaceutical industry experience in a technical or supporting technical role
• 2 years leading or supporting GxP System implementation and validation
• Bachelor of Science in Engineering or comparable life science degree.
• Proficient with the Microsoft Office Suite Word Excel PowerPoint and Project
• Experience with quality systems such as deviations change control and CAPAs required.
• Strong professional interpersonal and communications skills both verbal and written for providing clear direction for the business vendors and internal stakeholders.
• Ability to meet deadlines and multitask efficiently.
• Must be comfortable in a fastpaced environment with minimal direction and changing priorities.
• Proven ability to support and encourage cross functional collaborative work environment.
• Proven ability to work independently with limited guidance.

Preferred Education Skills and Knowledge

• 2 years of experience in a Quality role is highly desirable
• Experience with Master Control or comparable GMP document management system preferred
• Experience with Blue Mountain RAM or comparable asset management system preferred

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 .

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