Manager, DEA Compliance
Company: Cambrex
Location: Whippany
Posted on: January 27, 2023
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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 policiesAnticipate 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
necessaryDevelop 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 planningPerform capacity analysis related to the
manufacture, storage, and shipment of scheduled drug products.
Train, mentor, and develop staffOther 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
arenaUnderstanding 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 facilityMust be able to remain sedentary for
periods of timeRequired 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.PI202131081
Keywords: Cambrex, New York , Manager, DEA Compliance, Executive , Whippany, New York
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