Quality & Regulatory Operations Specialist

Cencora•Whitestown, NY

1d•Onsite

About The Position

This role is in support of Cencora's distribution services in the US operating through our AmerisourceBergen business. The Quality & Regulatory Operations Specialist monitors the overall compliance program at the operating level and works closely with the CSRA Manager. This position demonstrates an ability to resolve routine issues, identifies non-routine issues, and proposes or takes actions to resolve them. The specialist assists in reviewing and releasing C2 orders, reviews blanks for completeness after they have been filled, and tracks and maintains records as per regulatory requirements. They also assist in formulating general safety policies and procedures in compliance with local, state, and federal OSHA regulations, and inspects the facility to detect existing or potential accident and health hazards, recommending corrective measures. The role involves participating in the investigation of compliance-related incidents and accidents, coordinating training programs related to security, regulatory compliance, and Health & Safety, and maintaining compliance, safety, and security files. Additionally, the specialist assists with internal audits to ensure compliance with DEA, DOT, OSHA, and PDMA regulations, prepares and maintains regulatory reports, brings potential diversion activities and security breaches to the attention of management, and operates as a liaison for the DC with Federal, State and local regulatory agencies in the CSRA Manager’s absence. The role also establishes and promotes the maintenance of a safe, accident-free and healthy work environment.

Requirements

High school diploma or equivalent
2 + years directly related experience in compliance, regulatory, or distribution environments.
Knowledge of legal and regulatory compliance regulations
Knowledge of Federal, State and local regulatory agencies
Ability to communicate effectively both orally and in writing
Good interpersonal skills
Good mathematical skill
Strong organizational skills; attention to detail
Ability to follow and interpret government regulatory requirements and changes
Ability to implement processes resulting in satisfactory audit practices
Knowledge of Microsoft Word, Excel and PowerPoint

Responsibilities

Monitors the overall compliance program at the operating level and works closely with the CSRA Manager.
Demonstrated ability to resolve routine issues, identifies non-routine issues, and proposes or takes actions to resolve them.
Assists in reviewing and releasing C2 orders, reviews blanks for completeness after they have been filled.
Tracks and maintains records as per regulatory requirements.
Assists in formulating general safety policies and procedures in compliance with local, state, and federal OSHA regulations.
Inspects facility to detect existing or potential accident and health hazards; recommends corrective measures. Keeps associates abreast of the dangers of working with hazardous substance.
Participates in the investigation of compliance-related incidents, under the direction of the CSRA Manager or CSRA Director.
Participates in the local investigation of accidents and work-related injuries.
Assists with the coordination of all training programs related to security, regulatory compliance, and Health & Safety to ensure compliance with corporate standards, as well as State and Federal laws and regulations.
Maintains compliance, safety, and security files.
Assists with internal audits to ensure compliance with DEA, DOT, OSHA, and PDMA regulations. Prepares and maintains regulatory reports and listings.
Brings potential diversion activities and security breaches to the attention of the CSRA Manager; identifies areas of vulnerability and proposes reconciliation procedures.
In the CSRA Manager’s absence, operates as liaison for the DC with Federal, State and local regulatory agencies.
Establishes and promotes the maintenance of a safe, accident-free and healthy work environment.
Performs related duties as assigned.