Quality Control Analyst II, Quality Control - Raw Materials

Overview

Iovance Biotherapeutics is a growing, late-stage company focused on the development and commercialization of novel cancer immunotherapies. Iovance is seeking an Analyst II, Quality Control (QC) Raw Materials, who will be responsible for the sampling, release testing, data review, and vendor qualification, for all raw material lots received for use in the manufacturing of product at the Iovance iCTC site. These activities include chemical and biological raw materials, component inspection, and final packaging.

A good understanding of QC test methods and raw materials release requirements per USP and EP compendia, is desired. Experience working in a GMP-regulated environment is essential. The position will report to the Manager, Quality Control - Raw Materials.

Specific Responsibilities

• Perform day-to-day activities for raw material release operations.

• Perform Acceptable Quality Level (AQL) sampling and inspection.

• Perform Carbon Dioxide (CO2) sampling and testing.

• Support technical review of AQL, CO2 testing, and other raw material releases.

• Support all quality events and tasks associated to raw material release.

• Author, review, and/or execute SOPs, protocols, reports, specifications, and other quality control documents as applicable.

• Support raw materials vendor qualification program.

• Support efforts in on-going readiness for regulatory inspections and compliance audits.

• Participate in investigations for out-of-specification test results, corrective actions, and verification of effectiveness.

• Support problem solving for technical issues, pertaining to raw material testing and release.

• Operate at a consistent and exemplary level of efficiency, producing high quality and accurate results, in a fast-paced environment.

• All duties are performed with supervision and oversight.

Education and Qualifications

• Bachelor's degree in a relevant discipline (biological sciences or equivalent).

• Minimum (2) years in a GxP regulated setting (pharmaceutical or biotechnology industry); experience with cell and/or gene therapy products is a plus.

• Excellent organizational skills with the ability to work on multiple projects with varying complexity and timelines.

• Strong analytical and technical background in compendial testing and related equipment, including wet chemistry, FT-IR, UV/VIS, KF, Titration, and GC methodologies.

• Experience in raw material inspection and testing practices.

• Experience with quality events, including OOS investigations.

• Strong technical background and familiarity with laboratory control operations and quality systems.

• Experience with lab and data management systems (LIMS, Empower, Phenix).

• Broad knowledge of biological drug development with respect to Quality Control.

• Demonstrated ability to communicate with external partners with respect to quality control activities.

• Extremely detail-oriented with strong analytical, written, and verbal communication skills.

• Ability to effectively manage multiple priorities involving aggressive timelines at a high level of productivity.

• Demonstrate sense of urgency; ability to recognize time sensitivity.

• Flexible and adaptable style with an eagerness to take on challenges.

• Comfortable in a fast-paced company environment with minimal direction and able to adjust workload based on changing priorities.

• Problem solver who not only identifies issues but leads efforts to resolve them.

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 25 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.

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