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Job Type: *Full Time Regular Location: Kansas City, MO
Job Description:
Come be part of the exciting growth happing at MRIGlobal. Due to a demand for our services MRIGlobal has developed a new position for aRepository Operations Manager. This position will oversee the cGMP warehouse activities including but not limited to inventory control, shipping/receiving, internal material movement, transportation (private and commercial) and hazardous material handling.
This position will report to MRIGlobal's Pharmaceutical Sciences Section Manager while supporting the warehouse operations by procuring, tracking and forecasting all raw pharmaceutical materials, active Ingredients, manufacturing consumables and other necessary supplies. Along with coordinating with Program Management, Analytical Groups and Purchasing, this person will be responsible for coordinating with outside vendors, to determine projected materials usage in order to meet the demands of the related schedules. Additional responsibilities may include;
* Initiating purchase requisitions and coordinating with Project Management, Purchasing and Quality Control to ensure that sufficient inventories are maintained and materials are available when needed.
* Coordinating with manufacturing, customers, and contract courier services to facilitate shipping and receiving system.
* Maintaining an accurate inventory while following appropriate regulations as needed and perform cycle counting. This person will need to provide documentation on all pharmaceutical material transactions such as issues and returns.
* Controling the receipt of pharmaceutical materials and applicable procedures until dispositions have been completed by Quality Control.
* Segregating rejected pharmaceutical materials and coordinating their destruction and disposal in a safe manner and in concurrence with corporate, state and city regulations.
* Ensuring that materials stored in the cGMP warehouse are held under specified storage conditions, properly labeled and within expiration or retest dates.
* Issuing released pharmaceutical materials to Manufacturing for use in production, maintaining a First In / First Out (or First Expiry / First Out) rotation of inventory. Assist in staging of materials for manufacturing in specified areas.
* Complies with established safety guidelines and proper handling of hazardous materials. Maintains pharmaceutical warehouse area and inventory management systems in an audit ready state at all times.
* Training and supervising personnel performing receiving and shipping functions for the facility.
To be Successful you will need;
* Knowledge in the development, manufacture and scale up of pharmaceutical products.
* Proficient skills with material management software and Microsoft Office products and the Ability to learn new software/systems.
* Understanding of GMP and FDA guidelines and how they relate to Pharmaceutical materials management and manufacturing.
* Demonstrated experience working directly with government agencies to include U.S. Customs & Border protection, FDA, USDA and DEA.
* Experience in managing bulk pharmaceutical material storage and distribution, a high volume, high throughput pharmaceutical warehouse and distribution operation center.
* Ability to plan, assess priorities, meet objectives, be detailed oriented and possess strong problem solving aptitude.
* Ability to manage pharmaceutical materials and inventories within a regulated industry while ensuring compliance with federal, state and local agencies to include the EPA, FAA, DEA, DOT, EEOC, OSHA, and FDA; demonstrated knowledge of IATA codes and cold chain management.
* Ability to understand and compose SOP's.
* Ability to provide operational oversight and perform logistical responsibilities of a high volume pharmaceutical warehouse and distribution operation.
* Ability to plan and forecast material needs related pharmaceutical scale-up and understanding of the GMP and regulations which apply to the manufacturing of pharmaceutical products.
* Understanding of national and international shipping regulations as it pertains to pharmaceutical materials.
Minimum Qualifications
Bachelor's degree in Business or related discipline, or equivalent experience with a minimum of five years GMP Warehouse and Materials Management experience. Must have certification in transportation of hazardous materials.
We are proud to be an EEO/AA employer M/F/D/V. We maintain a drug-free workplace and perform pre-employment substance abuse testing.
