Job Description

The Controlled Substance Specialist position is responsible for the Controlled Substances and List 1 Chemicals at the site from the point of receipt of the materials, throughout the process and to the point of receipt of the finished product by the customer. This includes leading the development & maintenance of an environment that is committed to compliance with DEA regulations for the handling of Controlled Substances and List 1 Chemicals. 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.

This is a full-time role for our 3rd Shift, working Monday through Friday from 10:00 PM to 6:30 AM. This is a set, consistent schedule and based on site in our Sugar Land, Texas location. This is a safety sensitive position that may be subject to random drug testing, in accordance with applicable laws.

What the Job Controlled Substance Specialist Does Each Day:

• Ensures procedures are established, maintained and followed to prevent, detect and investigate the diversion of Controlled Substances and List 1 Chemicals
  Maintains records of every movement of Controlled Substances and List 1 Chemicals from the point they are received by the company until they are received by the designated recipient
• Monitors the daily use of Controlled Substances and List 1 Chemicals throughout the process to assure people and processes are in a continuous state of compliance with DEA regulations, company policies and procedures and safety requirements
• Updates department Standard Operating Procedures (SOPs), investigates variances, and executes change controls to support compliance objectives
  Establishes & maintains cooperative cross-functional relationships with peers in other departments including Quality, Manufacturing Operations, Supply Chain and Pharmacy Services to meet plant objectives
• Completes in-process checks & verifications of Controlled Substances and List 1 Chemicals in alignment with Standard Operating Procedures
  Reviews documentation, such as batch records, to ensure recording of processes, logs, and accounting of materials is in compliance with policies, procedures, and Good Documentation Practices (GDP)
• Prepares, executes, and maintains Order Forms (222) for each transfer of Schedule II Controlled Substances
• Initiates Notices of Events (NOE) and investigates Deviations, and takes appropriate corrective action to eliminate non-compliant conditions and to prevent recurrence
  Performs and records regular inventories to ensure complete and accurate records of all stocks on hand
• Establishes procedures and work instructions in compliance with regulatory, site, and corporate requirement
• Assists in developing training programs & assures site level training is conducted with the objective that people are able to handle Controlled Substances and List 1 Chemicals in a compliant manner
• Partners with cross-functional teams to review operational performance, and drive improvement through the initiation and execution of corrective and preventive actions and change control assignments for equipment, documentation, or processes
• Frequent physical transfer of bulk materials and cased finished good products to and from controlled substance storage locations

Our Most Successful Controlled Substance Specialist have / are:

• Working knowledge of DEA regulatory requirements as well as all applicable SOPs
• Working knowledge of safety standards, and their application, to continuously improve the safety culture and metrics
• Ability to communicate compliance requirements
• Ability to influence and persuade peers on cross-functional teams, and resolve conflicts with peers
• Prioritizes and plans work activities based upon priorities and criticality of issues
• Maintains attention to detail
• Demonstrated Time-Management skills
• Defines performance goals and measures performance against the objectives
• Effectively partner with cross-functional teams
• Computer Skills
• Microsoft Office Suite
• ERP software, INFOR a plus

Minimum Requirements for this Role:

• Associate degree required; Bachelor’s degree preferred
• 1-2 years relevant experience to include Project Management, operations, regulatory compliance and/or pharmaceutical experience
• 1-2 years relevant experience working with Controlled Substances and knowledge of DEA regulations
• Working knowledge of DEA regulatory requirements as well as all applicable SOPs
• Working knowledge of safety standards, and their application, to continuously improve the safety culture and metrics
• Ability to communicate compliance requirements
• Ability to influence and persuade peers on cross-functional teams, and resolve conflicts with peers

Any of the Following Will Give You an Edge:

• 2-4 years’ experience in a regulated cGMP environment

Benefits of Working at Quva:

• Comprehensive health and wellness benefits including medical, dental and vision
• 401k retirement program with company match
• 17 paid days off plus 8 paid holidays per year
• 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 pharmacy. Quva Pharma’s multiple production facilities and industry-first dedicated remote distribution capabilities provide ready-to-administer sterile injectable medicines critical to patient care. Quva BrightStream partners 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. Quva’s 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. Quva's 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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