Specialist - Quality & Regulatory

Cencora•Williamston, MI

1d•Onsite

About The Position

This role is in support of Cencora's distribution services in the US operating through our AmerisourceBergen business. The Specialist - Quality & Regulatory monitors the overall compliance program at the operating level and works closely with the Compliance Manager and the Regulatory Compliance Manager. This position assists in reviewing and releasing C2 orders, reviews blanks for completeness after they have been filled, and assists in counting and verification of inventory. The role also tracks and maintains records as per regulatory requirements, reviews Control Drug Substance reports/packing slips, and scans/files courier proof of deliveries. Additionally, the Specialist assists in formulating general safety policies and procedures in compliance with local, state, and federal OSHA regulations, consults with departments on safety matters, and inspects facilities for hazards. The role participates in accident investigations, coordinates training programs for safe practices (including DEA and OSHA training), and maintains compliance, safety, and security files. Internal audits are conducted to ensure compliance with DEA, DOT, OSHA, and PDMA regulations. The Specialist complies with all appropriate policies, procedures, safety rules, and DEA regulations, records daily warehouse temperature readings, and reviews forklift inspection sheets. They also assist with MSDS files, report potential diversion activities and security breaches, and act as a liaison between customer service and internal compliance, as well as between corporate associates and regulatory agencies. The role establishes and promotes a safe work environment and maintains all compliance, safety records, and security files for the Distribution Center, performing related duties as assigned.

Requirements

High School Diploma or GED
Minimum of 2 years' experience or more directly related and progressively responsible experience.
Experience in Compliance, SAP, SOP and Safety Data Sheets.
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; attention to detail
Knowledge of Microsoft Word, Excel and PowerPoint

Responsibilities

Monitors the overall compliance program at the operating level and works closely with the Compliance Manager the Regulatory Compliance 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.