Supervisor, Quality Control, Sample Management

Overview

The Supervisor, Quality Control, Sample Management will be responsible for sample inventory management as well as internal and external sample distribution, including storage and shipping of QC samples under appropriate conditions. This role  will be responsible for developing staff and onboard new team members.

Shift: 

• Sunday to Wednesday from 9am - 8pm
  

Or

• Wednesday to Saturday from 9am - 8pm

Essential Functions and Responsibilities

• Supervision and Development of direct reports (operators), mentoring/coaching to motivate and mentor peers/ staff, to foster a culture of continuous improvement and operational excellence.  
• Schedule and coordinate day-to-day activities, ensuring conformance to the daily schedule.  
• Perform review of batch documentation and logbooks for completeness and accuracy.
• Author and revise documentation, including drafting and approval of SOPs, Sample Plans, Deviations, CAPAs, etc.   
• Establish objectives and conduct performance reviews, monitoring progress toward objectives and provide timely feedback to Management.
• Manage all aspects of QC Sample Management for raw material, in-process, and final product samples including sample storage, sample inventory and reconciliation, scheduling, and shipping.
• Maintain sample integrity by ensuring that all samples are managed (i.e., stored; handled; shipped) in compliance with procedures, specifications, and cGMP.
• Ensure optimal performance of the iCTC QC logistics team through supervision and training.
• Ensure optimal vendor performance regarding sample management through adequate oversight.
• Provide timely distribution of samples internally at the iCTC, and externally to testing vendors.
• Ensure that sample inventory records are maintained and accurate.
• Create and/or improve procedures to ensure optimal compliance with cGMP.
• Maintain current knowledge base of regulations, corporate policies, and industry best practices, trends, and standards to ensure that the logistics function remains in compliance with applicable requirements.
• Support audits and inspections as needed.
• Must adhere to Iovance Biotherapeutics core values, policies, procedures, and business ethics
• Comply with safety SOP’s, SDS sheets, and laboratory procedures per company policy and OSHA regulations
• Act as a subject matter expert – Sample Management 
• Implement process improvement cross functional projects
• Review of completed monthly level 1 audits
• Responsible for approving procurement requests
• Responsible for ensuring accurate cycle counts are completed
• Adherence to GMP and SOP procedures including GDP 

Required Education, Skills, and Knowledge:

• Bachelor’s degree or 6 years of relevant GMP and Quality Sample Management experience
• Experience supervising a team with direct reports.
• Experience with inventory and/or logistics in the pharmaceutical industry.
• Quality mindset, familiar with 21 CFR Part 11 and standard GxP best practices and FDA regulations.
• Hands-on laboratory experience with sample handling, inventory, and cryo-shipping.
• Strong collaboration, time management, and organizational skills are required.
• Proactive, results oriented, self-starter with demonstrated strong leadership skills and experience in a complex manufacturing environment. 
• Detail-oriented with strong mathematical skills.
• Excellent written and verbal communication skills.
• Excellent judgment and creative problem-solving skills.
• Ability to work successfully in a fast-paced team-oriented environment.
• This position is for regular work week hours (M-F); however, due to the nature of cell therapy. manufacturing schedules, must be willing to work weekends, evenings, and holidays, as needed.
• Must adhere to Iovance Biotherapeutics core values, policies, procedures and business ethics.
• Remains current regarding current Good Manufacturing Practices (cGMP) guidelines and develops and/or modifies Sample Management methods to fully address compliance issues.
• Demonstrates strong oral and written communication skills and actively contributes to training, report generation and documentation (batch records, deviations, etc.). Strong technical writing ability required.
• Experience leading “development” initiatives, i.e., training, coaching, learning initiatives. 
  

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
• Ability to meet deadlines

Work Environment: 

• This position will work in an office, with occasional visits to the Quality Control labs. 
• 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 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.

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 our Candidate Privacy Notice. 

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