Position Overview

The Senior Operations Specialist has the overall responsibility for the planning, coordination, evaluation, and supervision of the operational activities and personnel. The Senior Operations Specialist works under the direction of the Head of NGS Lab, supervising operations personnel and demonstrates the organizational commitment to quality and compliance. The Senior Operations Specialist is a hands-on manager. The role covers areas such a supply chain management, inventory control, forecasting, shipping and receiving, QC, managing equipment, purchasing, Customer Service and processing customer orders.

The Senior Operations Specialist is responsible for training, supervising, periodically reviewing and documenting in the following areas: shipping and receiving, warehousing, distribution, sales order fulfilment of product, incoming inspection (quality control), inventory control, forecasting, creating purchase orders to replenish inventory of supplies and components.

Essential Duties and Responsibilities:

  • Operations:
    • Creates and reports on weekly/monthly lab and warehouse operations.
    • Manages “Key Performance Indicators” (KPIs) that measure the efficiency and effectiveness of OpGen’s operations and issues reports to OpGen Executive management and other stakeholders as needed. KPIs such as:
      • Throughput
      • Yield
      • Reject/scrap rates
      • Delivery performance
      • Backlog/open orders
      • Cost of operations
      • Cycle time.
    • Establishes and/or participates in preventive maintenance plans for equipment.
    • Completes all documentation related to lab and warehouse operations.
    • Responsible for inventory planning, scheduling, forecasting and control operations.
  • Receiving & Distribution:
    • Responsible for creating shipping orders.
    • Responsible for communicating sales orders confirmation and progression/status with customers.
    • Responsible for packaging, addressing and shipping finished goods per written SOPs.
    • Managing receipt of all incoming goods in accordance with existing SOPs.
    • If and when required, complete incoming materials inspection and complete appropriate documents.
  • Customer Support:
    • Manage operations team to support distributed products
      • Manages and tracks customer complaints and concerns
      • Assists customers when necessary
      • Documents all complaints within the QMS system to meet regulatory requirements.
  • Personnel:
    • Responsible for direction of operations personnel.
    • Ensure that resources are properly deployed to complete assigned tasks and duties.
  • Other:
    • Create, draft and revise SOPs and other critical documents.
    • Initiate and complete planned deviations, CAPAs and non-conformance documentation as required.
    • May be required to support customer complaint investigations.
  • Other duties as assigned.

Qualifications: Education and Experience: 

  • B.S. Degree, MS preferred in a related science
  • Minimum 5 years of related work experience
  • Proficient in using Microsoft Word, Excel, and PowerPoint
  • Experience with ERP, preferably Microsoft Business Central
  • Experience in distribution of FDA regulated IVD products preferred

Qualifications: Licenses and Other Credentials: 

  • Experience with Food and Drug Administration’s Quality System Regulations (QSRs), ISO 13485 and/or GMP preferred.

Employment Type:

  • Full-time.

 

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