Clinical Operations Specialist

Clinical Operations Specialist

Location: 770 Sumneytown Pike, West Point, PA 19486

Qualifications:

• 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.
• 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.
• M-F(7am-3.30pm EST).
• 1year assignment with a possibility of extension.
• Previous experience working in a fast paced environment with in logistic and warehouse distribution.

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.