Specialist, Quality and Regulatory Operations

Cencora•Corona, CA
•Onsite

About The Position

This role supports Cencora’s U.S. distribution services operating through its AmerisourceBergen business. The Specialist monitors operating-level compliance and works closely with the Compliance Manager and Regulatory Compliance Manager. The position supports regulatory records and audits, controlled substance order review, inventory verification, and facility safety programs. It also coordinates with internal departments, customers, corporate associates, and regulatory agencies to support compliance and maintain a safe, secure distribution center.

Requirements

  • Familiarity with regulatory matters gained through relevant education, completion of a two-year Associate’s Degree program, technical vocational training, or an equivalent combination of experience and education.
  • At least two years of directly related and progressively responsible experience.
  • 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 that result in satisfactory audit practices.
  • Strong judgment and ability to resolve issues effectively.
  • Ability to work independently and quickly and efficiently.
  • Effective oral and written communication skills.
  • Good interpersonal skills.
  • Good mathematical skills.
  • Strong organizational skills and attention to detail.
  • Knowledge of Microsoft Word, Excel, and PowerPoint.

Nice To Haves

  • Experience in compliance initiatives or contract administration for a public or private company is highly desirable.

Responsibilities

  • Monitor the operating-level compliance program and work closely with the Compliance Manager and Regulatory Compliance Manager.
  • Assist with reviewing and releasing C2 orders and checking completed blanks for completeness.
  • Assist with inventory counting and verification.
  • Track and maintain records as required by regulations.
  • Review controlled drug substance reports and packing slips.
  • Scan and/or file courier proofs of delivery for the division.
  • Assist in formulating general safety policies and procedures in compliance with local, state, and federal OSHA regulations.
  • Consult with departments on equipment design and use, fire prevention, and safety programs.
  • Inspect the facility for existing or potential accident and health hazards and recommend corrective measures.
  • Help keep associates informed about hazards associated with hazardous substances.
  • Participate in investigations of accidents and work-related injuries.
  • Assist in coordinating training to promote safe practices and safety awareness, including DEA and OSHA training for Distribution Center associates.
  • Maintain compliance, safety, and security files and records for the Distribution Center.
  • Conduct internal audits to ensure compliance with DEA, DOT, OSHA, and PDMA regulations.
  • Comply with applicable policies, procedures, safety rules, and DEA regulations.
  • Record daily warehouse temperature readings and review forklift inspection sheets.
  • Assist with maintaining the Distribution Center’s MSDS files.
  • Report potential diversion activities and security breaches to the Compliance Coordinator or Regulatory Compliance Manager; identify vulnerabilities and propose reconciliation procedures.
  • Act as a liaison between customer service and internal compliance requirements.
  • Liaise between corporate associates and federal, state, and local regulatory agencies.
  • Establish and promote a safe, accident-free, and healthy work environment.
  • Perform related duties as assigned.

Benefits

  • Medical, dental, and vision care.
  • Benefits and resources supporting physical, emotional, financial, and social wellness.
  • Support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave.
  • Training programs, professional development resources, mentorship programs, employee resource groups, and volunteer activities.
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