Bio Safety Operations Technician

vor 2 Monaten


Kelsterbach, Deutschland Marken Vollzeit

**Title**:
Biosafety Operations Technician

**Job Purpose**:
Under limited supervision, handling cryogenic freezer products including reception, storage and dispatch in an BSL-2/3 environment

The main purpose of the Operations Associate is to perform the day to day operational requirements of the work order as reception, storage and shipment preparation.

**Main Duties and Responsibilities**
- Coordinates, quality controls, and monitors the delivery of biosafety education and training to any and all Marken staff who work with or have potential for exposure to biological pathogenic agents.
- Receipt of pharmaceutical products in accordance with company procedures.
- Generation of shipping documentation upon receipt of shipment requests.
- Create inventory pick-lists within Depot Inventory Management System.
- Physical pick of supplies from within the Depot.
- Inspection of products picked for shipment by other associates.
- Preparation of shipment export documentation.
- Processing of shipment acknowledgment receipts.
- Filing of shipment documentation.
- Post shipment notification to clients.
- Stock control including periodic cycle counts
- Performance of labelling activities according GXP and internal Guidelines
- Preperation and processing of Destruction documents and physical collection
- Response to CMS alarms.
- Perform tasks related to Qualification and annual maintenance activities.
- Monitors all Marken Storage and Distribution in Frankfurt activities involving the use of hazardous biological materials for compliance with appropriate regulations, policies, procedures, and best practices.
- Reviews activities involving biohazardous materials and approves or recommends modifications to ensure safe practices; provides guidance and/or performs follow-up as appropriate.
- Informs and educates Marken staff regarding biosafety issues and develops comprehensive biosafety educational programs.
- Oversees the supervision of personnel, which includes work allocation, training, promotion, enforcement of internal procedures and controls, and problem resolution; evaluates performance and makes recommendations for personnel actions; motivates employees to achieve peak productivity and performance.
- Inspects depots for compliance with regulations and guidelines pertaining to the use, handling, and disposal of potential biohazards; coordinates the review and investigation of all biosafety accidents occurring at Marken, and develops corrective action plans.
- Develops and implements emergency response procedures for incidents involving biohazardous materials, and maintains Marken Incident Action Plan for biohazards; develops medical surveillance criteria for activities involving biohazards and related materials; responds to biohazardous materials incidents as appropriate.
- Serves as principal source of expertise regarding appropriate equipment, facilities, and work practices for protecting staff, and the environment from contamination and infectious organisms.
- Handling with LN₂ cryogenic freezer products including reception, storage and dispatch
- To adhere to all company Policies at all times.
- To undertake any other reasonable duties at the request of the Line Manager.

**Requirements**:

- Good command of English and fluent German
- A minimum of 2 years laboratory housekeeping experience (preferably in GMP facility)
- Associate degree level as laboratory technician or equivalent

**Marken** is a wholly owned subsidiary of UPS and is a critical part of UPS Healthcare. Marken offers a state-of-the-art GMP-compliant depot network and logistic hubs for clinical drug product storage and distribution worldwide, and supports cell and gene therapy logistics services from clinical to commercial, while maintaining the leading position for Direct-to-Patient and Home Healthcare services, biological sample shipments and biological kit production.

**Moving Our World Forward by Delivering What Matters.**

**#LI-LA1**
**IND123


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