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).

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