Abeona Therapeutics
Published
02/11/2020
Location
Cleveland
Category
Job Type
Contact Name
Ashley Jones
Street Address
6555 Carnegie Avenue, 4th Floor

Description

Position Overview

The Inventory Control Operator is a critical role supporting the GMP Manufacturing, Process and Assay Development and Quality Control functions at Abeona. This individual will support and lead the organization and management of inventory encompassing the receiving, quarantine and release spaces. The ICO will ensure adequate inventories of all supplies (several hundred different SKUs) for Manufacturing during clinical trials, initial commercial process, for process and assay development activities, cleaning of Manufacturing facilities and gowning of Manufacturing associates. The ICO will work with Abeona’s internal Buyer on continuous reviews of vendor quality to ensure effective and efficient acquisition of supplies. The ICO will be accepting supplies shipments, lifting, unboxing, and storing several items on a daily basis and cooperating with Quality Control on supplies release process.

Essential Duties and Responsibilities

  • Must be flexible, adaptable and always ready for new information and change of plans.
  • Must be able and willing to be Point-of-Contact for all receiving activities
  • Organize and record supplies in GMP Manufacturing, Quality Control, Assay and Process Development labs.
  • Daily and routine restocking of GMP Manufacturing with gowning, cleaning, routine, approved  and/or specific supplies.
  • Support development of needed SOPs and complete all duties in compliance with existing SOPs.
  • Work with GMP Manufacturing, labs and the Buyer on ordering needed supplies.
  • Determine GMP Manufacturing volumes of supplies needed on hand to warrant continuous uninterrupted operation.
  • Collaborate with the Buyer to determine effective supply options.
  • Determine which GMP Manufacturing supplies need to be on hand/which can be held at the supplier and shipped weekly/monthly.
  • Support Buyer and Supplier Quality to systemize inventory with supporting software and/or databases.
  • Facilitate and support Quality Control in releasing quarantined supplies to Manufacuring.
  • Must execute all duties in collaboration with all Abeona Team members, be an engaged team player and communicate effectively.
  • Perform other duties as required.

Qualifications

  • Bachelor’s degree in Biological Science or related field.
  • Minimum of one (1) year quality and/or manufacturing experience in a pharmaceutical, biotech, or biologics GMP regulated manufacturing environment.
  • Must be organized, always able to receive new information and show a high attention to detail.
  • Demonstrated proficiency in cGMP, basic arithmetic, planning, tracking, prioritization and timelines with a hands-on approach.
  • Capable of executing actions based on written instruction.
  • Ability to work across all levels and functions of an organization and operate independently.
  • Excellent written and oral communication and presentation skills.
  • Intermediate skills in Microsoft Office and especially in Excel.
  • Fluent in English (oral and written).

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to experience prolonged sitting, some bending, stooping, and stretching. Hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required. A normal range of hearing and vision correctable to 20/20 is required. Occasional lifting up to 20 pounds is required.

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