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DEA Specialist

Company: Thermo Fisher Scientific
Location: Rockford
Posted on: May 19, 2019

Job Description:

Job DescriptionPosition Summary: The DEA Specialist is responsible for controlled substance compliance in the areas of research and development, manufacturing, and distribution at the Rockford, Illinois site of Thermo Fisher Scientific. Specifically, the position ensures compliance to DEA regulations, including prevention of any diversion of regulated materials, monitoring and reporting inventory status of regulated materials and verification of the effectiveness of security procedures. Upon identification of a weakness in security and inventory practices, identify, implement and document improved procedures for compliance and security. The position is also responsible for general site security functions, including educating personnel and promoting adherence to security and regulatory policies and requirements.The position requires leadership, excellent written and oral communication, critical thinking and problem-solving skills as well as unquestionable integrity. The DEA Specialist reports to the Senior Manager, QA.Key Responsibilities: Implement, manage and maintain systems for the receipt, storage, and transfer of controlled substancesManage, complete and submit ARCOS Reporting and Year End Reports (YERS)Coordinate with Environmental, Health and Safety group controlled substance reverse distribution (disposal)Maintain DEA-related SOPs and Work InstructionsMonitor the use of DEA222 order forms for compliance with DEA requirementsOversee annual procurement quotaManage controlled substance inventory compliance and reconciliation, and monitor all associated activitiesInvestigates suspected diversion activitiesConduct internal site audits for continuous improvement of the controlled substance program and to ensure DEA inspection readinessManage site card access systemManage site DEA inspectionsRemain current with industry practices/trends and regulatory agency expectations governing controlled substance handling and reportingLiaise with state and federal agencies as requiredCollect and analyze data related to the compliance and security systemsDevelop and present training to the site on DEA and security requirementsParticipate, as needed, on new product teamsPerform all job duties in a safe manner and obeys all safety policies and procedures and regulatory or statutory requirementsPerform all job duties consistent with the Code of Ethics and the 4-I valuesPerform other duties and cross training as assignedMinimum Requirements/Qualifications: Associate degree preferred in a regulatory, quality or scientific discipline3 or more years experience in a manufacturing or distribution environmentKnowledge of ISO 9001 and cGMP regulations, preferredWorking knowledge of DEA Regulations, preferred. At a minimum applicant should have knowledge of DEA and/ or other federal regulations concerning controlled substancesExperience as a trainer/coach, preferredHigh ethical standards, integrity and strength of character in his/her personal and professional dealings and a willingness to act on and be accountable for his/her decisionsStrong written and oral communication skills including an ability to communicate effectively with multiple levels of staff throughout the organizationPossess strong organizational skills with the ability to manage and prioritize multiple tasks and meet deadlinesEmployee must be self-motivated with the ability to work as a team player and/or independently and willing to ask for and offer help when neededExercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutionsImplement new programs/processes with little directionThis position has not been approved for Relocation Assistance.If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, click here for further assistance. Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Keywords: Thermo Fisher Scientific, Rockford , DEA Specialist, Other , Rockford, Illinois

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