About The Position

Work as part of a Team to execute production tasks for their appropriate areas in a Good Manufacturing Practice (GMP) manner under direction from Senior/Lead Technicians or Supervisors. Able to identify appropriate tasks and perform basic functions independently without additional guidance or supervision. Able to learn and perform more complex tasks related to the function of the appropriate area. Maintain training and compliance with site safety and quality requirements. This role is part of a shift, with specific requirements for start and stop times and requires onsite presence five days a week.

Requirements

  • Ability to repetitively lift, carry, push and pull up to 50 lbs. required for Packaging and Warehouse roles
  • Ability to quickly learn new systems required
  • Demonstrate competency and in-depth knowledge of all processes, methods and procedures related to GMP environment and area-specific tasks
  • High School Diploma or equivalent required
  • Growth mindset
  • Team player
  • Desire to learn packaging operations
  • Excellent interpersonal and communication skills.

Nice To Haves

  • Clinical Supply Chain Management
  • ERP Financial Systems
  • Forklift Operations
  • GMP Compliance
  • Good Manufacturing Practices (GMP)
  • Inventory Accuracy
  • Inventory Control Management
  • Logistics Coordination
  • Materials Handling
  • Production Planning
  • Proper Documentation
  • Safety Training Programs
  • Shipping and Receiving
  • Shipping Management
  • Space Utilization
  • Standard Operating Procedure (SOP)
  • Supply Chain Metrics
  • Team Player
  • Transportation Logistics
  • Warehouse Administration
  • Warehouse Shipping and Receiving
  • Warehouse Storage

Responsibilities

  • Maintain cGMP and safety training to site requirements
  • Follow cGMP, Standard Operating Procedure (SOP) and safety requirements in all activities
  • Report potential quality events, non-conformance to GMPs/SOPs when observed
  • Ensure all paperwork is properly executed using Good Documentation Practices
  • Occasional overtime and weekend work may be requested
  • Interact with employees within own department as well as frequent interactions with employees from other groups/departments
  • Perform incoming material receipt, clinical site drug returns and sample management
  • Receive, inspect and store all warehouse inventory
  • Execute sample collection activities
  • Perform inventory functions such as weekly replenishment, posting of Excess & Obsolete inventory and min/max changes
  • Coordinate and execute discard process for, but not limited to, expired and non-available inventory
  • Process order management and material staging in support of packaging/labeling work centers
  • Emergency cold vault coverage, when needed
  • Perform regular cycle counts, ensuring system inventory accuracy
  • Manages shipping activities, freight and logistics functions (pick, pack, label, schedule, ship)
  • May be assigned to coordinate and/or prioritize warehouse activities
  • Creation of Packaging documents according to SOPs.
  • Ensures correct documentation of transactions within SAP.
  • Documentation according to Good Documentation Practice (GDP) Guideline.
  • Check of correct content of written Good Manufacturing Practice (GMP) documents.

Benefits

  • medical
  • dental
  • vision healthcare
  • other insurance benefits (for employee and family)
  • retirement benefits, including 401(k)
  • paid holidays
  • vacation
  • compassionate and sick days
  • annual bonus
  • long-term incentive
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