The Formulation Inventory Specialist is responsible for leading and optimizing inventory control responsibility which includes verification of dispensed controlled and non-controlled Active Pharmaceutical Ingredients (API), cycle counts and maintenance of inventory utilizing perpetual inventory systems. This position plays a critical role in maintaining a compliant, audit-ready environment and ensuring adherence to DEA regulations, cGMPs, company policies, and safety requirements. At Quva, you will be an essential part of a mission-driven organization dedicated to expanding critical access to quality, affordable medication and data insights while promoting a culture of innovation, collaboration, and continuous improvement. What the Formulation Inventory Specialist Does Each Day: Manages the receipt, storage, movement, and reconciliation of controlled and non-controlled substance APIs, ensuring accuracy and traceability throughout the formulation process Performs and documents regular cycle counts and periodic inventories to ensure complete and accurate records of all inventory on hand including participation in annual and biannual inventories Maintains detailed records of all movements of Controlled Substances and List I Chemicals from receipt through final disposition, in accordance with DEA requirements Oversees inventory management for non-controlled APIs and excipients and leads discrepancy investigations, including root cause analysis and resolution planning Determines appropriate corrective and preventive actions (CAPA) for inventory variances Ensures procedures are established, maintained, and followed to prevent, detect, and investigate diversion of Controlled Substances and List I Chemicals Monitors daily usage of Controlled Substances, List I Chemicals, and non-controlled APIs to ensure continuous compliance with DEA regulations, cGMPs, company SOPs, and safety requirements Initiates and supports Notices of Events (NOEs), deviations, and investigations, implementing corrective and preventive actions to prevent recurrence Completes in-process checks and verifications of materials in alignment with approved SOPs and work instructions and escalates appropriately Reviews batch records, logs, and inventory documentation to ensure compliance with Good Documentation Practices (GDP) Updates and authors SOPs, work instructions, and forms related to API inventory control and material handling Executes change controls related to inventory processes, documentation, or equipment as required Accurately transacts inventory movements in ERP systems (INFOR preferred) Establishes and maintains strong cross-functional relationships with Quality, Manufacturing Operations, Supply Chain, and Pharmacy Services to support production and plant objectives Partners with cross-functional teams to review inventory-related performance metrics and drive continuous improvement initiatives Assists in the development and delivery of training programs to ensure employees are qualified to handle controlled and non-controlled APIs in a compliant manner Performs frequent physical transfer of bulk APIs and cased finished goods to and from controlled and non-controlled storage locations Leads audits and inspections by providing documentation, inventory data, and subject-matter expertise Interprets regulatory requirements and translates them into operational procedures Advises leadership on inventory risk, compliance exposure, and process improvements Establishes controls and policies governing inventory handling and reconciliation Other duties as assigned
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Job Type
Full-time
Career Level
Entry Level
Education Level
Associate degree
Number of Employees
251-500 employees