Dea compliance associate - united states, philadelphia
adecco is looking for dea compliance associate for a client in philadelphia, pa. the ideal candidate will be responsible for the following:
assure dea regulatory compliance through state and dea registration activities, dea purchase, sales, and import/export activities, state, federal and foreign regulatory activities, customer satisfaction, and operational efficiency. keep abreast of all dea regulations, changes, rulings and current industry practices to address organizational business needs. monitors and insures proper documentation requirements for appropriate regulatory compliance.
specific duties, activities, and responsibilities included but are not limited to:
• responsible for supporting all departments with immediate needs regarding our dea compliance documentation requirements.
• responsible for assuring that documentation is maintained in accordance with cgmps and sops which includes auditing and record retention.
• maintaining documentation in support of regulatory agency inspections and internal audits.
• support activities related to controlled substances and listed chemicals, including record keeping, reporting, acquisition, storage, distribution, importing, and exporting.
• responsible for providing support to clients regarding organization and communication of clinical site licensing requirements.
• assistance in researching regulatory issues impacting clinical supply services to develop appropriate action plans.
• assist in maintaining a precise inventory of controlled substances.
• data entry for reporting into automation of reports and consolidated order systems (arcos) for manufacturer and distributor registrations to the dea.
• assist in reporting to other regulatory bodies for controlled substance activity as appropriate.
• ensure compliance as it pertains to catalent sops and regulatory requirements.
• support activities related to the trackwise system.
• provide support for client and government audits of the controlled substances areas.
• additional duties and projects as deemed necessary for improvements and/or compliance.
• provide additional support to quality assurance departments as needed.
• audit vault and cage related documentation and logbooks.
• other tasks as assigned.
position requirements:
• knowledge of relevant cgmps and dea regulations.
• capable of quickly learning various software systems including inventory system, access databases, and internet-based systems.
• excellent communication, organizational and writing skills.
• working knowledge in ms word, excel and other ms office components.
• results oriented.
• detail oriented.
• ability to work under pressure with multiple tasks and deadlines.
• must be a self-starter, be able to work independently and have the ability to multi-task under strict deadlines.
• mathematical and reasoning ability.
• ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
• ability to work effectively under pressure to meet deadlines. individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds. specific vision requirements include reading of written documents and use of computer monitor screen frequently.
• individual’s primary workstation is located where the noise level is low.
education or equivalent:
• college degree preferred with some experience in quality assurance and/or dea compliance
experience:
• minimum of two years’ experience in the pharmaceutical industry"
if you are interested and met the requirements of this position please click apply to be considered, thank you in advance.
equal opportunity employer/veterans/disabled
the company will consider qualified applicants with arrest and conviction records
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