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Manager, DEA Compliance

Company: Cambrex
Location: Whippany
Posted on: January 27, 2023

Job Description:

CambrexLocations: Whippany, New JerseyCategories: Supply ChainReq ID: 2924This position is responsible for implementing and enforcing the rules and regulations governing the manufacture, warehousing, processing, packaging, labeling, distribution, and reconciliation of all classes of controlled substances as stipulated by the Federal Drug Enforcement Agency, and relevant State and Regional agencies.

  • Complete all required periodic reports and inventories in a timely and accurate manner.
  • Ensure the site is aligned to produce and ship scheduled substances through accurate completion of all required DEA documentation such as quota applications, inventories, destruction, shipping forms, etc.
    • Plan and implement security procedures required for operational control at all stages of manufacturing, packaging, labeling, processing, warehousing, and distribution of Scheduled Drug Substances.
    • Recognize the importance of documentation, as it relates to control of operations.
    • Keep current on changes to DEA Schedules and policies
    • Anticipate the expectations during a DEA inspection of the facility.
    • Prepare written Standard Operating Procedures (SOPs) which will provide for 100% control of the schedule-identified substances operation.
    • Collaborate with site engineering to assess all internal security systems and drive improvements as necessary
    • Develop policies and procedures for inventory control and material handling that are consistent with company-wide policies and procedures
    • Develop and maintain annual and monthly material plans in support of quota management and applicable to company-wide materials planning
    • Perform capacity analysis related to the manufacture, storage, and shipment of scheduled drug products.
    • Train, mentor, and develop staff
    • Other projects as required and assigned
      • Bachelor's Degree (four year college or university) or equivalent job experience.
      • 5 years of experience working in a pharmaceutical environment in the security and DEA arena
      • Understanding of the obligations imposed upon all DEA registrants to compliment the basic requirements of FDA Current Good Manufacturing Practices (CGMPsPhysical Requirements:
        • Must be able to move about the facility
        • Must be able to remain sedentary for periods of time
        • Required to wear personal protective equipmentCambrex is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.PI202131053

Keywords: Cambrex, New York , Manager, DEA Compliance, Executive , Whippany, New York

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