Quality Control Compliance Investigator I contract - Philadelphia, United States - Iovance Biotherapeutics Inc
Description
Iovance is hosting an onsite Job Fair.
Where:
_Iovance Cell Therapy Center (iCTC)_
Location:
_300 Rouse Blvd Philadelphia, PA 19112_
Date:
_ Monday, June 24, 2024_
Time:
_12pm to 6pm (EDT)_
What to bring:
U_pdated resume_
We are Hiring We look forward to seeing you at the Job Fair.**
Overview
Iovance Biotherapeutics is a growing, late-stage company focused on the development and commercialization of novel cancer immunotherapies. Iovance is seeking a Quality Control (QC) Compliance Investigator who will in advance and close QC related investigations. Strong technical writing skills are required. Experience in a CAR-T or TIL environment is a plus.
Essential Functions and Responsibilities
- Performs deviation investigations for all areas within Quality Control
- Perform out of specification investigations with an emphasis on QC analytical assays (flow cytometry, ELISA, and other cellbased assays) and microbiology assays
- Work crossfunctionally to create relevant corrective/preventative actions (CAPA).
- Support maintenance of a database in support of QC metrics and KPI's.
- Revise quality documents in support of deviation mitigation and/or CAPAs.
- Support programs to improve ontime closure rates for all quality records
- Other responsibilities as determined.
Required Education, Skills, and Knowledge
- Bachelor's degree in a relevant discipline (biological sciences or equivalent)
- 13 years of experience in the biopharmaceutical industry within a cGMP Quality Control role
- Basic knowledge of biological drug development with respect to Quality Control
- Extremely detailoriented with strong analytical, written, and verbal communication skills
- Demonstrate sense of urgency; ability to recognize time sensitivity
- Flexible and adaptable style with an eagerness to take on challenges
Preferred Education, Skills, and Knowledge
- Experience with cell and/or gene therapy products
- GMP regulated laboratory experience
- Knowledge of investigation writing
The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully.
Physical Demands and Activities Required:
- Must be able to Sit for an extended amount of time in front of the computer or biological safety cabinet
Mental:
- Clear and conceptual thinking ability; excellent judgment, troubleshooting, problemsolving, analysis, and discretion; ability to handle workrelated 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.
LI-onsite
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