Controlled Substance Compliance Associate

• 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 example 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 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 as needed: VI and labeling, testing and method validations, etc
• Execute all inventory reconciliation and expire 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
• 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 development and growth of a Security culture among all colleagues and contractors to help ensure CS compliance

• 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
• Familiarity with and/or willingness to learn ERP system tracking and management

Previous work experience in a regulated manufacturing industry a plus

• Competitive salaries
• 401(k) plan with a company matching contribution
• Medical, vision and dental
• Health savings account (HSA)
• Holiday/paid time off