Manager Controlled Substances Associate

12/7/21

Cherry Hill, NJ

1487


Manager Controlled Substance

The incumbent should have the ability to guide and support all DEA regulated business activities involved in the pharmaceutical manufacturing, analysis, importing, exporting and distribution of controlled substances. These activities include licensing, procurement, recordkeeping, chain of custody, production, shipment and destruction. This position should also have the ability represent the company by interfacing with governmental agencies.

  • Regular and predictable onsite attendance and punctuality.
  • Act as DEA Coordinator by managing and coordinating all DEA related actives at the Cherry Hill and Eatontown facilities.
  • Conduct year‐ end and biennial inventory and report ARCOS quarterly reporting through the DEA website.
  • Coordinate all movement and chain of custody transfers for all control substances throughout manufacturing and support operations.
  • Ensure clear and efficient methods for maintaining accountability of all controlled substances are being developed and implemented.
  • Review and develop policies and procedures relating to controlled substance compliance.
  • Work with purchasing/logistics in the importation/exportation of controlled substances.
  • Monitor and Coordinate the destruction activities for all controlled substances with the Quality, Environmental, Health & Safety and Logistic departments.
  • Work with the Security department to implement and maintain security control measures relating to the safekeeping of controlled substance.
  • Conduct procurement activities as needed to ensure manufacturing operations has sufficient CII Quota available to meet sales demand.
  • Maintain a state of inspection readiness throughout all Controlled Substance Compliance activities.
  • Work with the Operational Excellence group to identify and execute continuous improvement opportunities.

QUALIFICATIONS

  • Minimum: Bachelor’s degree or equivalent with 5‐7 years’ work experience or an equivalent overall level of knowledge based upon previous work experience

EXPERIENCE

  • Preferred:Experience in injectable manufacturing

SKILLS

  • Must have strong interpersonal skills and the ability to communicate with all levels of manufacturing operations.
  • Able to adapt to changes in priorities based upon shifting business needs.
  • Proficiency in inventory management and other controlled substance compliance systems (SAP, CSOS, etc.).
  • Familiar with working in a cGMP environment and compliance with FDA regulations.
  • Must show strong initiative in self-development and a desire for continued growth. Asks for help from others and utilizes all available resources to ensure progress is continuously being gained.
  • Strong knowledge of DEA regulations and how they are met in a pharmaceutical manufacturing environment.
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