Clinical Operations Specialist - I (Assistant) - Talent Software Services, Inc.

*** s West Point Distribution Center mission is to provide a high level of service, agility, and flexibility to the patients we are privileged to serve. Our responsibilities include Processing of Sales Orders, Stock Transfer Orders to keep the supply chain and clinical sites stocked with clinical finished goods. In addition, we serve as customer support for internal stakeholders by processing international and domestic orders in SAP, coordinate shipping priorities between One Planning, Master Planning and Distribution. Lastly, receive bulk drug product, packaging components and keeping the packaging floor stocked for production.

The Warehouse/Distribution Technician I will be responsible for supporting the West Point MRL Logistics Warehouse with a focus on; Material Receipts, Inventory Management, Warehouse and Distribution (Shipping and Logistics) Operations. Adherence to regulatory, global and site policies and procedures governing operations activities is critical.

The shipments these positions would support are for Clinical Trials.
Responsibilities:
" Familiarity with cGMP and GDP
" Responsible for incoming material receipt, clinical site drug returns, sample management and pick, pack, ship of clinical drug shipments
" Understand and apply regulatory/ compliance requirements relative to the role
" Receive, inspect, and store all warehouse stock
" Performs inventory functions such as weekly replenishment, posting of Excess & Obsolete inventory and min/max changes
" Ensure that all paperwork is properly executed
" Perform duties and activities per SOPs
" Emergency cold vault coverage
" Ensuring system inventory accuracy
" Interact with employees within own department as well as frequent interaction with employees from other groups/departments
" Performs shipping activities, freight, and logistics functions pick, pack, label, schedule, ship
" Ability to prioritize work and activities per stakeholder needs
" Special assignments as needed
" Occasional overtime and weekend work may be required
" Performs all tasks related to warehousing and distribution while following appropriate client health and safety guidelines respecting current GMP S for investigational products, adhering to the shipping order instructions and SOP S.
" Preparing bulk and finished goods for shipment per all requirements while following the standard operating procedures (SOP S) (e.g. GMP s Cold Chain, country regulations, etc.), packing out shipments according to shipping temperature requirements while following SOP s cGMP s (FDA and EU) and receiving bulk and finished goods and components.

Quals--
Education Requirements:
" High School Degree or Equivalent with 0 3 years related experience, or BA/BS Degree with 0 2 years related experience.

Required:
" 0 - 3 years of experience in warehouse and logistics operations.
" Strong written and verbal communication skills.
" Microsoft Office experience.
" SAP Experience preferred.
" Solid ability to maintain accurate records.
" Ability to repetitively lift, carry, push, and pull up to 50 lbs.
" Knowledge of mathematics and analytics.
" Familiarity with all processes, methods and procedures related to GMP environment, warehouse, logistics and supply chain.

Preferred:
" Ability to quickly learn new systems
" cGMP experience in the pharmaceutical industry
" Knowledge of CFR regulation
" Experience within clinical trial space is nice to have.

Personality:
" Team player
" Individual contributor
" Excellent written and verbal communication skills
" Self motivated
" Self starter

Note:
" Positions available: 5.
" Onsite role at west point,PA.
" M-F(7am-3.30pm EST).
" 1year assignment with a possibility of extension.