Quality Assurance Quality Control, Senior Specialist

Overview

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 QAQC Specialist will work alongside QC personnel, helping to ensure that the highest standard of work is performed.

Essential Functions and Responsibilities

• Helps to ensure compliance to cGMPs and facility procedures. Interface with functional groups, such as Quality Control and Document Control, to determine events (errors, deficiencies, discrepancies, deviations and other observations) and report to management.
• Review of QC testing documentation records, raw material qualifications, EM data, and related documentation, ensuring resolution of all identified issues prior to lot disposition.
• Support method validation, qualification, verification, and transfers as needed.
• Work with internal functions to address all identified issues in a timely manner.
• Reports errors, deficiencies, discrepancies and observations to management.
• Review of Quality Assurance Records related to QC including investigations and deviations.
• 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
• Perform miscellaneous duties as assigned.

 Required Education, Skills, and Knowledge

• A Bachelor’s Degree in Science, Engineering, or a related technical discipline.
• At least five years of experience in a regulated industry.
• Working knowledge of cGMP regulations and other relevant standards.
• Prior experience with an aseptic processing environment.
• Prior experience with review of QC data specific to cell therapy testing required.
• Prior experience with method validation and transfer required.
• Strong administrative skills including use of Microsoft Word, Excel, and PowerPoint.
• Attention to detail.

Preferred Education, Skills, and Knowledge

• Knowledge of QMS systems.

Additional Requirements

• Weekend hours as needed for release of product.

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 remain in a stationary position standing or sitting for prolonged periods of time.
• Must be able to work on a tablet or computer for 80% of a typical working day.
• Must be able to move and lift 15 pounds.
• Wear proper personal protective equipment when in the warehouse, laboratory setting, i.e., safety glasses, lab coats, and closed-toed shoes.

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
• Ability to meet deadlines

Work Environment:

• This position will work in both an office and a manufacturing setting.
• Potential exposure to noise, 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.

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