Quality and Regulatory Operations Specialist

7 days ago

Sugar Land, United States AmerisourceBergen Services Corporation Full time
About the Role

We are seeking a highly skilled and experienced Quality and Regulatory Operations Specialist to join our team at AmerisourceBergen Services Corporation. As a key member of our organization, you will play a critical role in ensuring compliance with regulatory requirements and maintaining a safe and healthy work environment.

Key Responsibilities
  • Monitor and maintain compliance with regulatory requirements, including DEA, DOT, OSHA, and PDMA regulations.
  • Assist in reviewing and releasing C2 orders, and reviewing blanks for completeness.
  • Count and verify inventory, and track and maintain records as per regulatory requirements.
  • Control Drug Substance report/packing slip review, and scan and/or file courier proof of deliveries.
  • Assist in formulating general safety policies and procedures, and consult with departments on equipment design and use.
  • Inspect facilities to detect existing or potential hazards, and recommend corrective measures.
  • Assist in keeping associates abreast of hazardous substance dangers, and participate in accident and work-related injury investigations.
  • Coordinate training programs to increase safe practices and safety consciousness, and maintain compliance, safety, and security files.
  • Conduct internal audits to ensure compliance with regulatory requirements.
  • Comply with all appropriate policies, procedures, safety rules, and DEA regulations.
  • Record daily warehouse temperature readings, and review forklift inspection sheets.
  • Assist with maintenance of MSDS files, and bring potential diversion activities and security breaches to the attention of the Compliance Coordinator or Regulatory Compliance Manager.
  • Act as liaison between customer service and internal compliance requirements, and operate as liaison between corporate associates and Federal, State, and local regulatory agencies.
  • Establish and promote a safe, accident-free, and healthy work environment, and maintain all compliance, safety records, and security files.
Requirements
  • Familiarity with regulatory matters, developed through relevant educational training or equivalent combination of experience and education.
  • Relevant experience in accountancy, regulatory affairs, compliance, or similar vocations, with a minimum of two (2) or more directly related and progressively responsible experience.
  • Knowledge of legal and regulatory compliance regulations, Federal, State, and local regulatory agencies, and 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, quickly and efficiently, and communicate effectively both orally and in writing.
  • Good interpersonal skills, mathematical skills, and strong organizational skills and attention to detail.
  • Knowledge of Microsoft Word, Excel, and PowerPoint.
About Cencora

Cencora is a company that provides compensation, benefits, and resources that enable a highly inclusive culture and support our team members' ability to live with purpose every day. We offer a comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness, including support for working families, training programs, professional development resources, and opportunities to participate in mentorship programs, employee resource groups, volunteer activities, and much more.

We are an equal opportunity employer and welcome applications from diverse candidates. If you are a motivated and experienced professional looking to join a dynamic team, please submit your application.

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