Over de functie
The Controlled Substance Compliance Lead 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 Lead 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.
- Track and communicate batch release status (delays due to deviations/unplanned events), raw material availability and inventory levels.
- Act as point of contact for all Controlled Substance inquiries when Controlled Substance Specialist is not on site.
- Ensure Inventory transactions are occurring within a timely manner and communicate any bottlenecks or gaps in transaction flows appropriately.
- Assist CS Compliance reporting by preparing and submitting monthly/quarterly/annual reports (i.e. ARCOS) and state specific reporting.
- Complete and manage incoming and outgoing DEA 222’s with Schedule II transactions in instances when Controlled substance Specialist is not on site.
- Oversee and assist with monthly Inventory Audits to prevent diversion.
- 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, Controlled substance Disposal Logs, Transfer Forms.
- Support Aseptic Compounding and Filling teams throughout 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.
- Communicate with operations, post-production, and FSS Labs as needed to request support as needed: 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 record.
- Continuous monitoring of material accountability records for errors, completions of review and verification signatures.
- 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.
Maak het verschil
- 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, straight-forward, and professional manner in order 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.
Wat bieden wij?
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.