Quality Control Analyst I, Microbiology
1 month ago
Overview
The Quality Control Analyst will support quality control testing operations at Iovance’s Cell Therapy Center (iCTC). The quality control testing programs include in-process and final drug product microbial testing such as bioburden, endotoxin, gram stain, environmental monitoring, and sterility techniques.
Essential Functions and Responsibilities
- Perform daily cGMP quality control laboratory microbiological testing activities at the iCTC facility.
- 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.
- Perform all activities with respect to cGMP compliance.
- Support thorough cGMP investigations for out-of-specification test results.
- Perform Environmental monitoring Data trending.
- Support technical problem solving.
- Support product stability programs including execution of stability testing, stability data analysis, and final reporting of stability data.
- Operate at a consistent and exemplary level of efficiency, producing high quality and accurate results.
Required Education, Skills, and Knowledge
- Bachelor’s degree in a relevant discipline (biological sciences or equivalent)
- Minimum one (1) year 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.
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 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 a 10-hr day 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 lab setting.
- When in the lab, must be able to work in a 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. If you need assistance or accommodation to apply to one of our opportunities, please contact careers@iovance.com.
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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