Quality Control Specialist II, Compliance Investigator [Contract to Hire] Philadelphia, PA

Iovance Biotherapeutics, Inc.; Philadelphia (Philadelphia County); On-site; USD 75,000 - 95,000; Full time

Job summary

A leading biopharmaceutical company is seeking a Quality Control Specialist II in Philadelphia. The role involves assisting in investigations related to QC compliance and ensuring quality standards in a GMP-regulated lab environment. Candidates should have strong analytical and technical writing skills, with a focus on detail and communication. This is a contract-to-hire position offering growth potential.

Qualifications

• Minimum of 5 years of experience in QC or related field required.
• Experience in a GMP-regulated lab environment is a plus.
• Must have strong analytical and communication skills.

Responsibilities

• Perform root cause analysis and investigations related to audits and deviations.
• Support investigations with an emphasis on analytical and Microbiology assays.
• Gather data and maintain a database of applicable metrics.

Skills

Analytical skills

Technical writing

Attention to detail

Communication

Education

Bachelor’s degree or equivalent work experience

Job description

Quality Control Specialist II, Compliance Investigator [Contract to Hire]

Philadelphia, PA

Overview

The Investigator II, Quality Control Compliance, will assist the QC Compliance Manager in advancing and closing 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 knowledge of writing investigations.

Essential Functions and Responsibilities

• Performs root cause analysis and investigations in response to audits, deviations, out of specification/lab investigations, and corrective/preventative actions (CAPA).
• Work cross-functionally to support deviations and Out of Specification investigations with an emphasis on analytical assays (flow cytometry, ELISA, and other cell-based assays) and Microbiology assays.
• Support investigations at multiple sites (IOVA-A and iCTC)
• Perform LIR investigations for OOS events and meet completion timelines.
• Gather data in support of deviations and maintain a trending database of applicable metrics.
• Revise Quality documents in support of deviation mitigation and/or CAPAs. Other responsibilities as determined.

Required Education, Skills, and Knowledge

• A minimum of 5 years of related experience with a Bachelor’s degree; or 3 years and a Master’s degree; or a PhD without experience; or equivalent work experience.
• 3-5 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
• Must be strong in presenting information to upper management

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. Please contact Human Resources to request an accommodation.

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 deadline
• 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.

#LI-onsite

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. If you need assistance or accommodation to apply to one of our opportunities, please contact [e-mail] .

By voluntarily providing information and clicking “Submit Application”, you explicitly consent to the collection and use of your personal information for the purposes described above and in our Candidate Privacy Notice .

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