Work hours: Monday - Friday, 8 hr shifts

Pay Rate: $22/hr

Work Location: Onsite

Quality Assurance provides quality oversight of the distribution of clinical trial materials (Drug Product and Ancillaries). The role is responsible for ensuring compliance with all applicable GMPs, GDPs, internal standards, procedures for distribution activities in the warehouse. Mix of desk-based administrative tasks and warehouse-based activities.

Day-to-day responsibilities:

  • Provide Quality verification of material data setup in computerized inventory management system.
  • Provide Quality verification of documentation related to receipt of non-modified commercial products and approving for these materials for distribution.
  • Perform Quality inspection of received materials to ensure alignment between documentation, computer system, and material. Release materials in computer system for distribution.
  • Perform Quality inspections of outgoing shipments for accuracy.
  • Inspect and verify re-stickering operations and release material for distribution following re-stickering.
  • Verify paperwork for damaged shipments.
  • Inspect and release undelivered orders.
  • Inspect and release redistributions.
  • Review and confirm Fit For Use determinations
  • Review and process EAP
  • Perform random cycle counts to confirm inventory records
  • Evaluate and approve Temperature Excursion Records
  • Initiation, complete and QA oversight of ICI’s.
  • Perform other duties as required.

Safety Equipment Required: Steel Toed Shoes, PPE - provided by the team



Requirements

  • Basic computer skills including Microsoft Office, Trackwise, QDoc and other web-based applications
  • Previous warehouse experience
  • Willingness/ability to work in a chilled environment (5 deg C)
  • Standing, lifting (up to 50 lbs.), and bending are required
  • Ability to work off hours and weekends
  • Must be able to pass background check and drug screen.

Benefits

KeyWords provides all its contingent workforce with:

  • Medical, dental and vision benefits
  • Paid time off (including sick and select holidays)
  • 401(k) enrollment with 3% employer matching
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