Operations Technician- Packaging Job at Kelly Science, Engineering, Technology & Telecom, Rahway, NJ

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  • Kelly Science, Engineering, Technology & Telecom
  • Rahway, NJ

Job Description

Operations Technician (1st shift 8:00-4:30)

Summary:

Responsible for performing all activities associated with timely packaging, labeling, warehousing, and distribution of bulk and finished good clinical materials. Also responsible for Compliance and Quality-related aspects of Global Clinical Supply Operations, including metrics capture, inventory management and ordering, Standard Operating Procedure (SOP) authoring, and supporting investigations and internal inspections.

Responsibilities:

  • Performs Packaging, Warehousing, and Distribution activities according to GMPs and appropriate safety requirements to meet exacting standards defined by the FDA and EU or other international regulatory agencies:
  • Primary and secondary packaging of drug products, and secondary packaging of biologics and vaccines.
  • Distribution activities, such as order processing, drug picking/packing/shipping.
  • Warehousing activities, such as bulk and component inventory movement and accuracy.
  • Manage the ordering and inventory levels for consumables.
  • Supports Quality oversight to the Operations area through the following:
  • Authoring or revising SOP's.
  • Supporting batch record reconciliation / review activities.
  • Supporting investigations with a focus on true root cause, and creation of appropriate corrective and preventative actions (CAPAs).
  • Participate as subject matter expert during internal or external audit from Quality group, safety bodies or regulatory agencies.
  • Supports creative problem solving, provides detailed analysis of issues and anticipates technical problems and obstacles. May liaise with other functions in Global Clinical Supply (GCS) or other partner groups.
  • Undertake specific projects within the group on as needed basis.

Education and Work Experience:

Bachelor's degree, or 5+ years equivalent work experience in related industry.

Knowledge, Skills, and Abilities:

  • Understanding of Good Manufacturing Practice (GMP) principles.
  • Knowledge of quality and safety requirements for pharmaceutical packaging / handling.
  • Detail-oriented and organized.
  • Excellent verbal and written communication skills.
  • SAP experience is highly desired.

Experience with Microsoft applications (Word, Outlook).

Job Tags

Work experience placement, Day shift,

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