Controlled Substance Compliance Lead - 3rd Shift

Over de functieSummary:The Controlled Substance Compliance Associate will support the DEA compliance profile by acting as the primary entity responsible for all the logistics associated with the daily activities for all Controlled Materials at Fagron Sterile Services.This is a dedicated position that executes the logistics associated with raw material and finished product movements and required documentation, coordinates sample inspection and transfer, VI and labeling, inventory reconciliation and correct disposal.Additionally, the Controlled Substance Compliance Associate will ensure that all CS-related activities occur in a consistent manner, and serve as liaison to other functional areas within FSS in support of an overall culture of awareness and DEA compliance.Responsibilities:Correct and consistent execution and documentation of all CS material transactions: Vault check-in/out, inventory reconciliation, sampling and disposal, finished product sales record. Some examples include: Perpetual Inventory Records, Reverse Distributor Manifest Forms (DEA Form 222 as applicable), Transfer Forms, Yearly Reconciliation Summary Forms.Support Aseptic Compounding and Filling teams throughout the manufacturing process: API check-out and transfer (electronic inventory) to PROD IN, return check-in of API and finished product, recording of consumption, finished product unit and reject count verification, line flush disposal, etc.Track and communicate batch release status (delays due to deviations/unplanned events), raw material availability, and inventory levels.Communicate with operations, post-production, and FSS Labs as needed to request support: VI and labeling, testing and method validations, etc.Execute all inventory reconciliation and expired inventory disposal activities.Maintain current electronic inventory in alignment with official paper records.Continuous monitoring of material accountability records for errors, completion of review, and verification signatures.Assist CS Compliance Management in preparing and submitting monthly/quarterly reports (i.e. ARCOS).Support operations by acting as SME in ensuring DEA and site procedure compliance for all daily activities.Assist with the development and growth of a Security culture among all colleagues and contractors to help ensure CS compliance.Wat wij vragenQualifications: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 in order to clearly convey priorities and needs.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 processes.Must be able to meet all requirements for handling controlled substances.Working knowledge of GDP principles as relating to a pharmaceutical manufacturing environment. Previous work experience in a regulated manufacturing industry is a plus.Familiarity with and/or willingness to learn ERP system tracking and management.Wat wij biedenWe offer a dynamic environment where talent and ambition can develop to its fullest. We have an open and informal organizational 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.Over het bedrijfFagron is the global market leader in pharmaceutical medicine, and its products are sold to more than 200,000 customers in over 60 countries. The goal of Fagron is: “Together we create the future of personalized medicine.” Fagron, together with prescribers, pharmacists, and customers, strives to improve medications and help the patient. From our position as market leader, we act locally and think internationally.

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