Quality Operations Specialist II Contract to Hire

Overview

The Quality Operations Specialist II is a part of the Quality Operations team. The Quality Operations team is responsible for ensuring that all operations at the facility comply with cGMP regulations as well as internal policies and procedures. The Quality Operations Specialist II works alongside manufacturing personnel helping to ensure that the highest standard of work is performed.

Shifts available:

Sunday to Wednesday from 7AM 6PM

Wednesday to Saturday 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.
• Review QC data
• Support lot release and closure.
• 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
• Initiate and participate in standard operating procedure (SOP) revisions to improve compliance.
• 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

• A Bachelors 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.
• Weekend and Shift work required.

Preferred Education Skills and Knowledge

• 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.

For the Visual Inspection Program the technician must be able to pass a Vision Exam that includes the following:

• Must not be color blind
• Must have 20/20 near vision in both eyes

Physical Demands and Activities Required:

• 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.
• 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 problemsolving analysis and discretion; ability to handle workrelated 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 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 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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