Quality Control Analyst II - Raw Materials 2nd Shift

**Contract to Hire**

Seeking a Quality Control (QC) Analyst in 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 sites. 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 Supervisor – Raw Materials.

***Shift is M-F 3pm – 11:30pm***

Essential Functions and Responsibilities

Perform and support day-to-day activities for raw material release operations, including Acceptable Quality Level (AQL) sampling and inspection, Carbon Dioxide (CO2) sampling and 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.

Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.

All duties are performed with supervision and oversight.

Other Duties, as assigned.

Required Education, Skills, and Knowledge

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

Minimum (3) years in a GxP regulated setting (pharmaceutical or biotechnology industry)

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 microbiology, potency, gel electrophoresis, 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.