Shift Hours:

Monday- Friday 8:00AM-4:30PM OR 7:30AM-4:00PM

This position is located onsite at our facility in Shakopee, MN. There is no option for remote or hybrid work. 

This role is supporting our AmerisourceBergen business, which offers supply chain services to healthcare providers and health systems in the United States.  

Under general supervision of Quality and Regulatory Operations (QRO) Manager or other management-level position in the facility, assists in all aspects of the Distribution Center’s regulatory compliance efforts and procedures. Assists in establishing and promoting the maintenance of a safe, accident free, and healthy working environment.

This position is categorized as compliance critical and, as such, requires and is assigned specific responsibility for ensuring continual and proper compliance with all division, corporate and regulatory requirements. Sufficient experience is required as well as the ability to function as an independent professional in the full management of these processes.  

• Monitors the overall compliance program at the operating level and works closely with the QRO Manager. 

• Assists in reviewing and releasing C2 orders; reviews blanks for completeness after they have been filled. 

• Assists in counting and verification of inventory. 

• Tracks and maintains records as per regulatory requirements. 

• Control Drug Substance report/packing slip review. 

• Scans and/or files courier proof of deliveries for the division. 

• Assists in formulating general safety policies and procedures in compliance with local, state, and federal OSHA regulations. 

• Consults with all departments on the design and use of equipment, fire prevention, and safety program. 

• Inspects facility to detect existing or potential accident and health hazards; recommends corrective measures. 

• Assists in keeping associates abreast of the dangers of working with hazardous substances. 

• Participates in the investigation of accidents and work-related injuries. 

• Assists with the coordination of training programs that will increase safe practices and safety consciousness, DEA and OSHA training for Distribution Center associates. 

• Maintains compliance, safety, and security files. 

• Conducts internal audits to ensure compliance with DEA, DOT, OSHA, and PDMA regulations. 

• Complies with all appropriate policies, procedures, safety rules and DEA regulations. 

• Records daily warehouse temperature readings and reviews forklift inspection sheets. 

• Assists with maintenance of the Distribution Center’s MSDS files. 

• Brings potential diversion activities and security breaches to the attention of the Compliance Coordinator or the Regulatory Compliance Manager; identifies areas of vulnerability and proposes reconciliation procedures. 

• Acts as liaison between customer service and internal compliance requirements. 

• Operates as liaison between corporate associates and Federal, State, and local regulatory agencies. 

• Establishes and promotes the maintenance of a safe, accident free, and healthy work environment. 

• Maintains all compliance, safety records, and security files for the Distribution Center. 

• Performs related duties as assigned. 

Education: 

Requires familiarity with regulatory matters developed either through relevant educational training through completion of a two year Associate’s Degree program, technical vocational training to equivalent combination of experience and education. Relevant experience generally would entail experience accountancy, regulatory affairs, compliance or similar vocations. Normally requires a minimum of two (2) or more directly related and progressively responsible experience. Experience in Compliance initiatives, or contract administration of a public or private company is highly desirable. 

Skills and Abilities: 

• Knowledge of legal and regulatory compliance regulations 

• Knowledge of Federal, State, and local regulatory agencies 

• Ability to follow and interpret government regulatory requirements and changes 

• Ability to implement processes resulting in satisfactory audit practices 

• Strong judgment and ability to resolve issues effectively 

• Ability to work independently 

• Ability to work quickly and efficiently 

• Ability to communicate effectively both orally and in writing 

• Good interpersonal skills 

• Good mathematical skill 

• Strong organizational skills and attention to detail 

• Knowledge of Microsoft Word, Excel, and PowerPoint