Quality Control Specialist II Sample Management Contract to Hire

Overview

The Quality Control Specialist II Sample Managementwillensure timesensitive distribution of quality control samples in support of QCrelated activities. They will be responsible for sample inventory management as well as internal and external sample distribution including storage and shipping under appropriate conditions for all the iCTC cell therapy asset.

Shift:

• Sunday to Wednesday from 9am 8pm
  

Or

• Wednesday to Saturday from 9am 8pm

Essential Functions and Responsibilities:

• Manage QC sample logistics for raw material inprocess and final product samples including sample storage sample inventory and reconciliation scheduling and shipping in LIMS based system.
• Maintain sample integrity by ensuring that all samples are managed (i.e. stored; handled; shipped) in compliance with procedures specifications and cGMP
• Provide timely distribution of samples internally and externally to testing vendors
• Ensure that sample inventory records are maintained and accurate
• 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
• Packaging of samples using temperature controlled dewars cold packs and dry ice
• Perform Quality Control activities
• Performs peer review of logbooks
• 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
• Complete training sessions and ensure training documentation is maintained
• Adherence to GMP and SOP procedures including GDP
• Perform cycle counts
• Assist in the generation and revisions of documentation inclusive of SOPs and Work Instructions
• Act as a subject matter expert in one to two areas
• Transfer of knowledge to new employees and peers
  

Required Education Skills and Knowledge:

• Bachelor degree or 2years of relevant GMP and Quality Sample Management experience
  
• Detailoriented with strong mathematical skills
  
• Excellent written and verbal communication skills
  
• Strong collaboration time management and organizational skills are required
  
• Proven ability to effectively collaborate with a wide range of stakeholders
  
• Excellent judgment and creative problemsolving skills
  
• Ability to work in a fastpaced and dynamic environment
  
• Handson laboratory experience with sample handling inventory and cryoshipping
  

Preferred Education Skills and Knowledge:

• Experience with inventory and/or logistics in the pharmaceutical industry

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 problemsolving analysis and discretion
• Ability to handle workrelated 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 equalopportunity 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 .

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