Overview

Iovance is seeking a highly motivated individual for the position of Quality Assurance Training Specialist I at Iovance’s Cell Therapy Center (iCTC) in Philadelphia PA. This position is responsible for supporting the Quality Document Control program at the iCTC facility and ensuring compliance to quality objectives and regulatory requirements. In addition, this position will be responsible for providing training and guidance to users on Iovance’ s Electronic Document Management System (EDMS).

Essential Functions and Responsibilities

• Assist in the development and/or review developed training materials.
• Maintain qualification training requirements in eLMS.
• Administer and assign training in eLMS
• Provide eDMS/eLMS End User Support
• Collaborate with Quality Assurance Document Control on training requirements impacting Document Change Control process.
• Supports training implementation in response to quality events
• Deliver training sessions, when applicable, and ensure training documentation is maintained. Ensure training schedules meet company production and quality targets.
• Assists functional groups with the creation or improvement of training content
• Continuously seek and support new approaches, practices and processes to improve the efficiency and efficacy of training.
• Adheres to Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs), including Good Documentation Practices (GDP).
• Supports documentation needs, which may include drafting and approval of SOPs, Work Instructions, Deviations, CAPAs, etc. Perform basic revisions as needed to accurately reflect current procedures.
• Attends meetings and escalates issues/concerns at that forum to Area Management for further investigation.
• May work on assignments that are moderately complex in nature, where judgment is required to resolve operational issues without negatively impacting manufacturing efforts.
• Ability to work in a team environment and independently as required.
• Contribute to department operations improvement in areas such as SOP revisions and department inspections.
• Other duties as assigned.
• Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
• Perform miscellaneous duties as assigned.

Preferred Education, Skills, and Knowledge

• Bachelor’s degree in Life Sciences discipline preferred, not required.
• Minimum of two (2) years of experience training and documentation in pharmaceutical or biopharmaceutical GMP based facility.
• Familiar with document change management and FDA quality systems
• Familiar with an eDMS system (MasterControl is a plus)
• Must possess a high level of attention to detail and proficient in Word and Excel
• Strong computer, organizational, and compliance skills
• Ability to work effectively on multiple projects simultaneously with minimum supervision.
• Strong interpersonal and communication skills

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