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Controlled Substance Compliance Supervisor
2 months ago
Controlled Substance Compliance Supervisor
Über die Tätigkeit The Controlled Substance Compliance Supervisor will support the DEA compliance profile by acting as one of the primary persons responsible for the logistics associated with the daily activities for all Controlled Substance Materials at Fagron Sterile Services. Additionally, the Controlled Substance Compliance Supervisor will serve as liaison to other functional areas within the FSS organization to support an overall culture of awareness and DEA compliance.
Responsibilities: This individual will be responsible supervision of the controlled substance vault leads and controlled substance document specialist. In addition to being able to independently perform the tasks listed in the job descriptions for the controlled substance vault leads, associates, and specialist this individual will be responsible for the following:
•Work with controlled substance management and various colleagues to develop training material for both new and existing CDAs and vault attendants, relating to incoming training and training associated with process changes/improvements.
•Work collaboratively with controlled substance team leads and other departmental leads to conduct training on topics relating to controlled substances.
•Work with controlled substance leads to develop weekly/daily schedules based on staffing, operation schedule and vault tasks needing to be completed.
•Periodic touchpoints with direct reports to ensure tasks are being performed timely and accurately.
•Working with controlled substance management to complete annual performance evaluations.
•Relaying important information relating to controlled substances; disseminating information to direct reports regarding production trends, initiatives, and issues. •Gathering, summarizing, and reporting operational metrics to your manager on a regular cadence.
•Provide operational improvement recommendations.
•Creating a positive work environment and helping team members achieve organizational goals.
Includes responsibilities of the Controlled Substance Compliance Associate:
· Support batch release and customer service teams by verifying and scrapping rejects and moving inventory to sellable locations in-order to process sales orders. Subsequently to release, vault associate will assist in pulling released product to fulfil sales orders and transfer to post-production staff for shipping.
· Ensure that all rejected materials are documented and destroyed appropriately. This may require communication with outside reverse distributors. Destruction includes rejected units from operations as well as liquid waste from operations and FSS labs.
· Correctly and consistently completing all required documentation for all above-mentioned controlled substance transactions. Form examples include Perpetual Inventory Records, Controlled substance Disposal Logs, Chain of Custody Forms.
· Assist team with routine inventory counts and reconciliation as often as and outlined in standard operating procedures.
· Ensure that product count aligns with official paper record (Perpetual log) as well as electronically (ERP system) upon completion of post-production activities, prior to release of product and over the course of sales transactions.
· Continuous monitoring of material accountability records for errors, completions of review and verification signatures.
· Clerical tasks including data entry, scanning, organizing, and storing of controlled documents.
· Support operations by acting as SME in ensuring DEA and site procedure compliance for all daily activities.
· Assist with development and growth of a Security culture among all colleagues and contractors to help ensure CS compliance.
Ihr Profil Qualifications:
Ihr Profil Qualifications:
· High School Diploma or equivalent required.
· Excellent time-management skills and ability to self-direct in managing concurrent requirements.
· Ability to communicate with colleagues, customers, suppliers, in person, on the phone, and by written communications in a clear, straightforward, and professional manner to clearly convey priorities and need.
· Excellent attention to detail and commitment to maintaining consistency and compliance with established procedures.
· Proactive, problem-solving mindset – ability to identify and correct errors, offer improvement recommendations, and willingness to embrace ownership of complex process.
· Must be able to meet all requirements for handling of controlled substances.
· Working knowledge of GDP principles as relating to a pharmaceutical manufacturing environment. Previous work experience in a regulated manufacturing industry a plus.
· Familiarity with and/or willingness to learn ERP system tracking and management.
Unser Angebot We offer a dynamic environment where talent and ambition can develop to its fullest. We have an open and informal organization culture, where individuals need to have strong motivation and ability to work independently. Fagron is a widely expanding, international, professional and ambitious pharmaceutical company with multiple growth opportunities. Job opportunity includes competitive salary, comprehensive benefits, performance package, and ability to be part of an international leader in an expanding industry.
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