Quality Control Technician I, Raw Materials

2 weeks ago

Philadelphia, Pennsylvania, United States Iovance Biotherapeutics Inc Full time
Job Overview

Position Title: Quality Control Analyst I, Raw Material

Company: Iovance Biotherapeutics Inc.

Salary: Competitive

Company Profile:

Iovance Biotherapeutics is a dynamic and innovative organization dedicated to the advancement and commercialization of cutting-edge cancer immunotherapies. We are currently seeking a Quality Control Analyst I, specializing in Raw Materials, to join our team. This role is pivotal in ensuring the integrity and quality of raw materials utilized in our manufacturing processes.

Key Responsibilities:

  • Conduct daily operations related to the release of raw materials.
  • Execute Acceptable Quality Level (AQL) sampling and inspections.
  • Perform Carbon Dioxide (CO2) sampling and testing procedures.
  • Assist in the technical evaluation of AQL, CO2 testing, and other raw material releases.
  • Engage in all quality-related activities concerning raw material release.
  • Draft, review, and implement Standard Operating Procedures (SOPs), protocols, reports, specifications, and other quality documentation as necessary.
  • Contribute to the vendor qualification program for raw materials.
  • Support ongoing readiness for regulatory inspections and compliance audits.
  • Participate in investigations of out-of-specification results, including corrective actions and effectiveness verification.
  • Assist in troubleshooting technical issues related to raw material testing and release.
  • Maintain a high level of efficiency and accuracy in a fast-paced environment.
  • Perform all tasks under supervision and guidance.

Qualifications:

  • Bachelor's degree in a relevant field (biological sciences or equivalent).
  • Minimum of two years of experience in a GxP regulated environment (pharmaceutical or biotechnology).
  • Strong organizational skills with the ability to manage multiple projects of varying complexity.
  • Solid analytical and technical expertise in compendial testing and related methodologies, including wet chemistry, FT-IR, UV/VIS, KF, Titration, and GC.
  • Experience in raw material inspection and testing protocols.
  • Familiarity with quality events, including out-of-specification investigations.
  • Proficient in laboratory control operations and quality systems.
  • Experience with laboratory and data management systems (LIMS, Empower, Phenix).
  • Comprehensive understanding of biological drug development concerning Quality Control.
  • Exceptional communication skills for interaction with external partners regarding quality control matters.
  • Detail-oriented with strong analytical, written, and verbal communication abilities.
  • Ability to manage multiple priorities effectively while meeting tight deadlines.
  • Demonstrated sense of urgency and adaptability to changing priorities.
  • Proactive problem solver with a focus on resolution.

Preferred Qualifications:

  • Experience with cell and/or gene therapy products is advantageous.

Physical and Mental Requirements:

  • Ability to wear appropriate Personal Protective Equipment (PPE).
  • Capable of standing and/or walking for the majority of a 10-hour workday.
  • Must possess near vision for close-range sample examination.
  • Ability to perform physical activities including bending, reaching, and lifting up to 25 pounds.

Work Environment:

  • This position involves both office and laboratory settings.
  • Exposure to various chemical and biochemical substances is expected.
  • Work in cleanroom environments with biohazards and human blood components may be required.

Iovance is committed to fostering a diverse and inclusive workplace. We are an equal opportunity employer and welcome applicants from all backgrounds.

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