Quality Control Analyst II, Quality Control - Raw Materials

at  Iovance Biotherapeutics Inc

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.

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.

• 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.