Quality Operations Specialist I

Overview

Iovance’s new cell therapy manufacturing facility will be operational in 2021 and Iovance is hiring for several open roles. We are seeking highly motivated Quality Operations Specialist to join the facility’s Quality Operations team. The Quality Operations team will be responsible for ensuring that all operations at the facility comply with cGMP regulations, as well as internal policies and procedures. The Specialist, Quality Operations, will work alongside manufacturing personnel, helping to ensure that the highest standard of work is performed.

Hours:

• This position is shift based, and onsite Wednesday through Saturday.
• The working hours will be assigned as either 9AM to 8PM or 7AM to 6PM as required.

Essential Functions and Responsibilities:

• Helps to ensure compliance to cGMPs and facility procedures. Interface with functional groups, such as Manufacturing, Quality Control, and Document Control, to determine events (errors, deficiencies, discrepancies, deviations and other observations) and report to management.
• Review batch records and related production documentation, ensuring resolution of all identified issues prior product disposition. Work with internal functions to address all identified issues in a timely manner. Reports errors, deficiencies, discrepancies and observations to management.
• Disposition incoming raw materials
• Apply quality compliance theories and principles to independently address a variety of issues of moderate scope. Provide guidance on controlled documents (content, quality, and document lifecycle), identifying gaps, addressing documentation needs, and suggesting process improvements
• Maintain and report on Quality Metrics.
• Initiate and participate in standard operating procedure (SOP) revisions to improve compliance. Maintain and report on Quality Metrics.

Basic Qualifications:

• A Bachelor’s Degree in Science, Engineering, or a related technical discipline.
• At least two years of experience in a regulated industry.
• Working knowledge of cGMP regulations.
• Prior experience and ability to work in an aseptic processing environment.
• Strong administrative skills including use of Microsoft Word, Excel, and PowerPoint.
• Attention to detail.
• Knowledge of QMS systems 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:

• Clarity of vision at near and mid-range, depth perception, ability to identify and distinguish colors.
• Must be able to wear appropriate clean room attire and all Personal Protective Equipment (PPE), i.e. scrubs, gowning coverall, 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.
• Ability to crouch, bend, twist, reach, and perform activities with repetitive motions.
• Ability to lift 20 lbs.

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:

• Able to work in cleanroom with biohazards, human blood components, chemicals, and variable noise levels.
• Works in production environment with exposure to latex and bleach.  Potential exposure to noise and equipment hazards and strong odors. 
• 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.

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.

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