Overview

The Quality Systems Specialist has experience in Quality Systems, QA, or Compliance in Pharmaceutical and/or Biotechnology companies. This individual is responsible for maintaining Quality Systems at Iovance’s manufacturing facility to ensure GMP compliance in accordance with country regulations and guidelines, as well as the company’s policies and procedures. They are an innovative, self-sufficient, self-motivated, and experienced candidate who takes ownership and accountability for quality at the facility. The specialist will support and oversee Quality System activities including deviations, CAPAs, and change controls. In this position, one is growth-oriented, have a continuous improvement mindset, and is someone who is passionate about working with others in a complex, changing, and fast-paced environment.

Essential Functions and Responsibilities

• Maintain the electronic Quality Management System (eQMS), with emphasis on change control, deviation, Out of Specification, Out of Trend, and CAPA processes
• Provide user support to the eQMS system users
• Generate status reports and support tracking of change controls, deviations, LIRs, and CAPAs to ensure timely closures of records
• Implement, enhance, and maintain QMS procedures and work instructions based on best practices or compliance requirements
• Support continuous improvement activities to increase the efficiency and effectiveness of the QMS
• Represent the Quality System and Compliance group in cross-functional projects where applicable
• May participate in internal audits or regulatory inspections (e.g., prep room participant, runner, scribe, etc.)
• Support training activities and back-up efforts for Quality Systems processes
• Support management with other Quality System and Compliance related tasks
• Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.

• Comply with Safety SOPs, SDS sheets, and laboratory procedures per company policy and OSHA regulations.
• Perform miscellaneous 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 with 3+ 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 direction and changing priorities
• Strong interpersonal skills and ability to work collaboratively with colleagues cross-functionally
• Strong computer skills including MS Office (Word, Excel, PowerPoint)

Preferred Education, Skills, and Knowledge

• Experience with an electronic QMS, MasterControl 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 wear appropriate clean room attire and all Personal Protective Equipment (PPE), i.e. scrubs, gowning coverall, masks, gloves, etc.
• Must meet requirements for and be able to wear a half-face respirator.
• Able to stand and/or walk 90% (and sit 10%) of a 10-hr day which may include climbing ladders or steps.
• Must be able to use near vision to view samples at close range
• Able to crouch, bend, twist, reach, and perform activities with repetitive motions.
• Must be able to lift and carry objects weighing 45 pounds.

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 deadline

Work Environment:

• This position will work in both an office and a manufacturing lab setting.
• When in the lab, must be able to work in Lab setting with various chemical/biochemical exposures, including latex and bleach.
• Able to work in cleanroom with biohazards, human blood components, and chemicals.
• Potential exposure to noise and equipment hazards and strong odors.

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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