Formulation Inventory Specialist

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

Our Most Successful Inventory Control Specialist:

• Working knowledge of DEA regulations and controlled substance handling requirements
• Understanding of cGMPs inventory controls and material management principles
• Knowledge of safety standards and commitment to continuous safety improvement
• Strong attention to detail with a high degree of accuracy
• Ability to clearly communicate compliance and inventory requirements
• Proven ability to influence and collaborate with crossâfunctional teams
• Strong organizational prioritization and timeâmanagement skills
• Demonstrated problemâsolving and investigation skills
• Proficiency in Microsoft Office Suite
• Experience with ERP systems (INFOR preferred)

Minimum Requirements for this Role:

• Associates degree
• 2 years of experience in pharmaceutical manufacturing inventory control materials management or a regulated production environment
• Handsâon experience handling controlled substances and/or regulated materials in compliance with established procedures
• Working knowledge of DEA regulations cGMPs and Good Documentation Practices (GDP)
• Experience performing inventory transactions reconciliations and investigations of discrepancies
• Ability to accurately complete and review batch records logs and inventory documentation
• 18 years of age
• Able to successfully complete a drug and background check
• Must be currently authorized to work in the United States on a full-time basis; Quva is not able to sponsor applicants for work visas

Any of the Following Will Give You an Edge:

• Bachelors degree or higher preferred

Benefits of Working at Quva:

• Set full-time consistent work schedule
• Comprehensive health and wellness benefits including medical dental and vision
• 401k retirement program with company match
• 17paid days off plus 8 paid holidays per year
• Occasional weekend and overtime opportunities with advance notice
• National industry-leading high growth company with future career advancement opportunities

About Quva:

Quva provides industry-leading health-system pharmacy services and solutions including 503B sterile injectable outsourcing services and AI-based data software solutions that help power the business of Pharmas multiple production facilities and industry-first dedicated remote distribution capabilities provide ready-to-administer sterile injectable medicines critical to patient care. Quva BrightStreampartners with health systems to aggregate normalize and analyze large amounts of complex data across their sites of care and through proprietary machine learning transforms data into actionable insights supporting revenue optimization script capture inventory management drug shortage control and more. Quvas overall progressive and integrated platform helps health-systems transform pharmacy management to achieve greater value and deliver highest-quality patient care.

Quva is an equal opportunity employer and is committed to creating and maintaining a work environment that is free from all forms of discrimination and harassment. Quvas Equal Opportunity Policy prohibits harassment or discrimination due to age ancestry color disability gender gender expression gender identity genetic information marital status medical condition military or veteran status national origin race religious creed sex (including pregnancy childbirth breastfeeding and any related medical conditions) sexual orientation and any other characteristic or classification protected by applicable laws. All employment with Quva is at will.

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Required Experience:

IC