Quality Control, Environmental Monitoring Analyst I - [Contract to Hire]

Iovance Biotherapeutics aims to be the 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. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, which may be a promising option for patients with cancer.

Overview

QC Environmental Monitoring Analyst I - will support the QC Environmental Monitoring (EM) operations at Iovance’s Cell Therapy Center (iCTC) and IOVA-A site.  The quality environmental monitoring program includes environmental monitoring of production facilities and utility systems, and data analysis. This position works across different shifts. Depending on your assigned shift, you may be required to work overtime, weekends, and holidays to complete assigned work.

Essential Functions and Responsibilities

• Perform daily GMP Quality Control laboratory activities at the iCTC facility with minimal to no errors while ensuring testing is completed in compliance with all applicable procedures, standards, and GMP regulations.
• Perform environmental monitoring of the cleanroom areas as scheduled including, but not limited to surface sampling, viable air sampling, non-viable air sampling, and utility sampling.
• Work in MFG cleanrooms with gowning and aseptic technique.
• Perform data trending, data analysis, and result reporting of microbiology EM data to support product lot release with adherence to turnaround times.
• Support technical problem-solving issues pertaining to GMP Quality Control.
• Operate at a consistent and exemplary level of efficiency, producing high-quality and accurate results.
• Support QC Compliance team in reporting and initiating EM excursions and procedural deviations.
• 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.
• Perform all activities for cGMP compliance.

Required Education, Skills, and Knowledge

• Bachelor’s degree in a relevant discipline (biological sciences or equivalent)
• Minimum one (1) year of experience in the pharmaceutical industry within a Quality Control role
• Successfully interface with multi-disciplined teams
• Extremely detail-oriented with strong technical skills
• Ability to effectively manage multiple priorities involving aggressive timelines at a high level of productivity
• High level of ownership and accountability
• Demonstrate sense of urgency; ability to recognize time sensitivity
• Proficient with using Microsoft Office applications (Outlook, Excel, Word, and PowerPoint)
• Previous experience with GDP, GLP, GMP

Preferred Education, Skills, and Knowledge

• Advanced degree (MSc. preferred.)
• Experience with cell therapy products is a plus.
• Environmental Monitoring experience (6 months- 1 yrs)
• Experience with Laboratory Information Management Systems (LIMS)

Physical Demands and Activities Required:

The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodation may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request accommodation. 

• Must be able to wear appropriate clean room attire and all Personal Protective Equipment (PPE), i.e., scrubs, gowning coveralls, masks, gloves, etc. for up to 4.5 hours per session.
• Able to stand and/or walk 90% (and sit 10%) of the scheduled workday 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 deadlines.

Work Environment:

This position will work in an office, laboratory, and a manufacturing setting. When in the lab, you may be exposed to various chemicals/biochemical, including latex, Spor-klenz, and bleach. Additionally, there is potential for variable noise levels, equipment hazards, strong odors, and other detergents/sanitizers. Able to work in cleanroom with biohazards, human blood components, and chemicals. Potential exposure to noise and equipment hazards and strong odors.

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