Specialist I, Quality Assurance (QA), IOVA-A QA Ops [Contract to Hire]

Overview

Specialist I, Quality Assurance (QA), IOVA-A QA Ops role is responsible for day-to-day Quality Assurance Operations activities. This role will work onsite alongside manufacturing and quality control personnel, helping to ensure that the highest standard of work is performed for Iovance’s in-house iPBMC manufacturing activities at 700 Spring Garden St, Philadelphia, PA., which is co-located at the American Red Cross Penn Jersey Region. This role is collaborative, organized, innovative, flexible, with a strong desire to learn and take ownership and accountability.

The Specialist I supports Quality Assurance lot release and disposition activities including process observation, batch record review, and completion of lot release documentation. The Specialist I supports Quality Assurance initiatives including, but not limited to, review of laboratory investigations and deviation investigations. The role supports internal teams and be able to effectively communicate bi-directionally in a complex, changing, and fast-paced environment.

2nd shift, Tuesday-Friday, 14:30-24:30

Essential Functions And Responsibilities

Quality Assurance Operational Support:

• Perform QA Operations activities that include review of manufacturing batch records and labeling/packaging operations to ensure timely release of cell therapy products.
• Support quality assurance processes, controls and batch history files for QA Operations and Lot Disposition
• Perform real-time, on-the-floor support for manufacturing production activities to ensure compliance with GMP and GDP quality initiatives, escalating issues as required.
• Track and communicate standard work completion and hurdles.
• Actively interact with Contract Manufacturing Organizations (CMO), and internal teams to ensure efficient and timely batch release.
• Maintain a collaborative and professional relationship with CMOs.
• Release of raw materials and inventory.
• Prepare and organize release documentation for approvals.
• Support internal audits and regulatory inspections.
  
  

Subject Matter Expertise

• Support the efficient and timely review of laboratory investigations and deviation investigations.
• Initiate and participate in standard operating procedure (SOP) revisions to improve compliance.
• Experience with cell therapy products and/or relevant skills.
  
  

General

• Ability to work effectively on multiple projects simultaneously.
• Excellent oral and written communication skills
• Must possess a high level of attention to detail.
• Ability to identify and resolve quality issues with others in a proactive, diplomatic, flexible, and constructive manner.
• Strong computer, organizational, and compliance skills. Proficient with Microsoft Office Suite, Word, Excel, and PowerPoint
• Must be comfortable in a fast-paced environment with changing priorities.
• Support QA and Logistics activities for on-going projects.
• Assist with implementing GMP QA procedures
• Other duties as assigned.
  
  

Required Education, Skills, And Knowledge

• BA/BS or equivalent in Biological/Physical/Chemical sciences, engineering, or equivalent focus of study from an accredited university or college.
• At least 2 years demonstrating proficient GMP QA/QC experience.
• Experience with use of an electronic QMS (i.e. MasterControl, Veeva)
• Familiarity with Code of Federal Regulations and International Council for Harmonization Guidelines governing current Good Manufacturing Practices for Pharmaceuticals
• Knowledge of GMP, Good Documentation Practices (GDP) and FDA quality systems.
  
  

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 perform cleanroom gowning and pass gowning qualification.
• Must meet requirements for and be able to wear a half-face respirator.
• 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 cleanroom setting. Potential exposure to latex, bleach, loud noise, lab equipment hazards, strong odors, and chemicals/biochemicals 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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