Senior Quality Assurance Specialist, Release

Overview

The Senior Quality Assurance Specialist, Release will support review of documentation and support releasing of materials and products. Th Senior Quality Release Specialist will also ensure compliance to Iovance procedures by supporting lot closure and deviation reviews.

The Senior Quality Assurance Specialist, Release will be on shift:

-Sunday to Wednesday 9AM – 8PM

-Sunday to Wednesday 2PM – 1AM

-Wednesday to Saturday 2PM – 1AM

Essential Functions and Responsibilities 

• 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.  
• Collaborate with internal functions to address all identified issues in a timely manner. Determine if the issue needs to be documented in the Quality System. 
• Coordinating release tasks as assigned to the Quality Release team by the schedule.  
• Collaborating lot release dates with cross functional teams for clinical release. 
• Reports errors, deficiencies, discrepancies, and observations to management that could impact product Quality on release. 
• Perform disposition of incoming materials and finished product. 
• Initiate and review of documentation for release. 
• Issuance of labels. 
• Support generation of Quality Metrics. 
• Ensure timely lot closure.  
• Support and review deviations, CAPAs, Laboratory Investigations, temperature excursions and other non-conformances. 
• 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 Bachelor’s Degree in Science, Engineering, or a related technical discipline. 
• At least five years of experience in a regulated industry. 
• Proficient knowledge of cGMP regulations. 
• Perform routine activities with minimal oversight. 
• Prior experience with review of QC data specific to cell therapy testing. 
• Strong administrative skills including use of Microsoft Word, Excel, and PowerPoint. 
• Extremely detail oriented with strong technical skills. 
• High level of accountability and ownership. 
• Demonstrate a sense of urgency ability to recognize time sensitivity. 
• Ability to effectively manage multiple priorities involving aggressive timelines at a high level of productivity. 
• Successfully interface with multidisciplined teams. 

Preferred Education, Skills, and Knowledge 

• Knowledge of Master Control QMS.

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 move about inside an office and exert up to 10 pounds of force occasionally or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects.
• Must have visual acuity to perform activities such as: preparing and analyzing data and figures, viewing a computer screen, and extensive reading.
• This position requires repetitive motion, substantial movements (motions) of the wrist, hands, and/or fingers.
• Must be able to communicate with others to exchange information.

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 deadlines.

Work Environment

This job works in a professional office environment and a manufacturing lab setting. Potential exposure to latex, bleach, loud noise, lab equipment hazards, strong odors, and chemical/biochemical is possible.  Requires operating standard office equipment and keyboards.

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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