Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Cold Room/Freezers -22degreesF/-6degrees C, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Warehouse, Will work with hazardous/toxic materials, Working at heights

Job Description

Join Thermo Fisher team to make a difference by aiding customers in healthcare and environmental protection.

Position Summary:

Maintain cGMP standards by handling Clinical Trial Materials accurately during receipt, storage, packaging, and dispatch.

Essential Duties and Responsibilities:Perform all processes in accordance with established procedures and cGMP standards.Maintain a high standard of housekeeping in the warehouse and be assigned as a backup cleaner when needed.Ensure that equipment and instruments in the work area are maintained and operating normally.Complete regular reports (as required by Management or client) pertaining to relevant work areas.Maintain accurate documentation for all processes conducted/performed.Assist management in any other matters as required.Coordinate all aspects of clinical trials supplies packaging, including supply forecast, batch record production, label production, and execution of the packaging exercise.Plan and schedule labelling and/or packaging jobs.Design and/or complete labelling and packaging instructions.Ensure that Investigational Medicinal Products (IMPs) are labelled and packed in accordance with each study protocol.Identify, evaluate, select, and manage third-party contractors for the production of labelling and packaging materials.Generate and complete batch records. Reconcile all packaging and labelling components.Generate batch records and production specifications for all packaging and labelling components.Produce Standard Operating Procedures and non-conformance reports.Initiate and implement continuous improvement activities on efficiency and quality.Assist in Warehouse – receipt, retrieval, Problem Reporting (PR), and dispatch of Clinical Trial Materials – when necessary.

ReceivingReceive, account for, and inspect all incoming shipments and deliveries.Stage or store materials in appropriate temperature conditions and warehouse locations.Complete documentation and update computer systems accurately.

DistributionProcess Pick Orders in a timely and accurate manner.Package Clinical Trial Materials in the accurate and appropriate shipping material.Ensure the appropriate project instructions are followed.Ensure the appropriate courier information is complete and available when presented to the couriers.Complete documentation and update computer systems accurately.

Export Shipment – QC checkCheck the accuracy of picked drug supplies against client orders and shipping distribution documents.Responsible for in-process checks for Just-In-Time Labeling.

Returns and DestructionReceive, account for, and inspect all returned shipments and deliveries.Retrieve and package all materials from inventory according to client instructions.Arrange for appropriate transport and/or destruction of materials according to client instructions.Complete documentation and update computer systems appropriately and accurately.Liaise with customers/site/internal departments on returns shipment arrangements.Generate monthly reports on returns shipment summary.