Quality Operations Specialist I Contract to Hire

Overview

Iovances new cell therapy manufacturing facility will be operational in 2021 and Iovance is hiring for several open roles. We are seeking highly motivated Quality OperationsSpecialistto join the facilitys 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. TheSpecialist Quality Operations will work alongside manufacturing personnel helping to ensure that the highest standard of work is performed.

Shifts available:

Sunday toWednesday from 7AM 6PM

Wednesday toSaturday from 7AM 6PM

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
• Support lot release and closure
• 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.
• Other tasks as assigned.

Basic Qualifications:

• A Bachelors Degree in Science Engineering or a related technical discipline or equivalent industry experience.
• 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 midrange 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 halfface respirator.
• Able to stand and/or walk 90 (and sit 10 of a 10hr 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 problemsolving analysis and discretion; ability to handle workrelated 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.
• 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.

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 individuals 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 .

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 ourCandidate Privacy Notice.

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