Operation Technician

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cold Room/Freezers -22degreesF/-6degrees C, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Warehouse

Job Description

When you’re part of the team at Thermo Fisher, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.

Position Summary:

To ensure the proper handling of Clinical Trial Materials – during receipt, storage, packaging and dispatch – in accordance with established procedures; and maintain the supplies and facility to cGMP standards.

Essential Duties and Responsibilities:

Perform all processes in accordance to established procedures and cGMP standards. Maintain high standard of housekeeping in the warehouse and be assigned as a backup cleaner in the event when the cleaner is absent from duty. Ensure that equipment and instruments in the work area is maintained and operating normally. Complete regular reports (as required by Management or client) pertaining to relevant work area(s).

Maintain proper documentation for all processes conducted/performed. Assist management in any other matters as required. Responsible for managing all aspects of clinical trials supplies packaging, including supply forecast, batch record production, label production, and execution of the packaging exercise. Planning and scheduling of labelling and/or packaging jobs. Design and/or execute labelling and packaging instructions. Ensure that Investigational Medicinal Products (IMPs) are labelled and packed in accordance with the requirements of each study protocol. Identify, evaluate, select and manage third party contractors responsible for the production of labelling and packaging materials. Generate and complete batch records. Responsible for reconciliation of all packaging and labelling components. Responsible for generation of batch records and production of specifications for all packaging and labelling components. Produce Standard Operating Procedures and non-conformance reports. Initiate and implement continuous improvement activities on productivity and quality. Assist in Warehouse – receipt, retrieve, Problem Reporting (PR) and dispatch of Clinical Trial Materials – when necessary.  Receiving

• Receive, account and inspect all incoming shipments and deliveries.
• Stage or store materials in the appropriate temperature conditions and warehouse locations.
• Complete documentation and update computer systems appropriately and correctly.

Distribution

• Process Pick Orders in a timely and accurate manner.
• Package Clinical Trial Materials in the correct 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 appropriately and correctly.

Export Shipment – QC check

-     Check the accuracy of picked drug supplies against client orders and shipping distribution documents

      -     Responsible for in-process check for Just-In-Time Labeling

Returns and Destruction

• Receive, account 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 correctly.
• Liaise with customers/site/internal department on returns shipment arrangement.
• Generate monthly reports on returns shipment summary.

Minimum Requirements/Qualifications:

“N”- or “O”-Levels Pass / Relevant experience in Logistics/Warehousing industry.

Non-Negotiable Hiring Criteria: (List 3-5 key quantifiable skills or position requirements that the candidate must have to be considered for this position.)

Need to be computer-literate and meticulous in his/her work. Demonstrates English literacy and basic numeracy. Working knowledge of Microsoft Office Suite (MS Word, Excel, PowerPoint, Outlook);

Work Schedule:

0830 AM to 1730 PM core hours, additional hours as required.