Controlled Substance Compliance Lead

• Correct and consistent execution and documentation of all CS material transactions: Vault check-in/out, inventory reconciliation, sampling and disposal, finished product sales record.
• 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
• dental
• health savings account (HSA)
• holiday/paid time off