Quality Control Specialist I, Compliance Investigator [Contract to Hire] Wednesday through Satu[...]

Iovance Biotherapeutics; Philadelphia (Philadelphia County); On-site; USD 60,000 - 100,000; Full time

Job summary

Join a dynamic and innovative firm dedicated to developing groundbreaking cancer immunotherapies. As a Quality Control Compliance Investigator, you will play a vital role in ensuring the integrity of quality processes within a GMP-regulated environment. Your strong technical writing and analytical skills will be essential as you conduct investigations and collaborate cross-functionally to implement corrective actions. This position offers a unique opportunity to contribute to life-changing therapies while working in a diverse and inclusive atmosphere. If you are detail-oriented and ready to tackle challenges in a fast-paced setting, this role is perfect for you.

Qualifications

• 1-3 years in biopharmaceutical industry within a cGMP Quality Control role.
• Experience in writing investigations and knowledge of biological drug development.

Responsibilities

• Perform deviation investigations and out of specification investigations.
• Create corrective/preventative actions and support QC metrics.

Skills

Technical Writing

Analytical Skills

Communication Skills

Problem-Solving

Attention to Detail

Time Management

Education

Bachelor's degree in biological sciences or equivalent

Tools

GMP Regulations

Quality Control Metrics

Database Management

Job description

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.

The ideal candidate will have experience working in a GMP-regulated laboratory with experience in writing investigations.

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 cell-based assays) and microbiology assays.
• Work cross-functionally 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 on-time 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).
• 1-3 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 detail-oriented 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. Reasonable accommodations may be made upon request to enable individuals to perform essential functions.

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, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines.

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.