Quality Control Analyst I - Microbiology

Overview

The Quality Control Analyst I- Microbiology will support quality control testing operations at Iovance’s

Cell Therapy Center (iCTC) and/or iPBMC manufacturing site (IOVA-A). The quality control testing

programs include in-process and final drug product microbial testing such as bioburden, endotoxins,

mycoplasma, gram stain, environmental monitoring, and sterility techniques. This position works across

different shifts. Depending on your assigned shift, you may be required to work overtime, weekends,

and holidays to complete assigned work.

Shift is Wednesday to Saturday from 7am-6pm

Essential Functions And Responsibilities

• Perform daily GMP Quality Control laboratory testing activities at the iCTC facility with minimal to no errors while ensuring testing is completed in compliance with all applicable procedures, standards, and GMP regulations.
• Perform environmental monitoring of the cleanroom areas as scheduled.
• Perform data analysis and result reporting of microbiology assays to support product lot release with adherence to turnaround times.
• Support technical problem-solving for issues pertaining to GMP Quality Control
• Support product stability programs, including execution of stability testing, stability data analysis and trending, and final reporting of stability data.
• Support generation and revisions of documentation, such as SOP, protocols and reports, deviations, laboratory investigations, CAPAs, and change controls
• Operate at a consistent and exemplary level of efficiency, producing high-quality and accurate results.
• Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
• Comply with Safety SOPs, SDS sheets, and laboratory procedures per company policy and OSHA regulations.
• Perform miscellaneous duties as assigned.
  
  

Required Education, Skills, And Knowledge

• Bachelor’s degree in a relevant discipline (biological sciences or equivalent)
• 0-4 years of experience in the pharmaceutical industry within a Quality Control role; experience with cell therapy products is a plus.
• Successfully interface with multi-disciplined teams
• Extremely detail-oriented with strong technical skills
• Ability to effectively manage multiple priorities involving aggressive timelines at a high level of productivity
• High level of ownership and accountability
• Demonstrate sense of urgency; ability to recognize time sensitivity
• Demonstrate a sense of urgency; ability to recognize time sensitivity.
• Proficient with using Microsoft Office applications (Outlook, Excel, Word, and PowerPoint)
  
  

Preferred Education, Skills, And Knowledge

• Advanced degree (MSc. preferred.)
• Previous experience with GDP, GLP, GMP is preferred.
• Experience with cell therapy products is a plus.
  
  

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 wear appropriate clean room attire and all Personal Protective Equipment (PPE), i.e., scrubs, gowning coveralls, masks, gloves, etc.
• Must meet requirements for and be able to wear a half-face respirator.
• Able to stand and/or walk 90% (and sit 10%) of the scheduled workday which may include climbing ladders or steps.
• Must be able to use near vision to view samples at close range.
• Able to crouch, bend, twist, reach, and perform activities with repetitive motions.
• Must be able to lift and carry objects weighing 45 pounds.
  
  

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.

Work Environment

This position will work in both an office and a manufacturing setting. When in the lab, you may be exposed

to various chemicals/biochemical, including latex and bleach. Additionally, there is potential for variable

noise levels, equipment hazards, strong odors, and other detergents/sanitizers. 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 equalopportunity

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 [email protected].

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