What are the responsibilities and job description for the Controlled Substance Specialist 2nd Shift position at QuVa Pharma, Inc.?
Our Controlled Substance Specialist plays a vital role in ensuring the highest quality and safety standards of our pharmaceutical products. Once you complete our training, you will be 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. Turn your passion for precision and your commitment to quality into a meaningful impact on healthcare across the US.
This is a full-time role for our 2nd shift, working Monday through Friday from 2:00 PM to 12:30 AM This is based on site in our Sugar Land, TX location. This is a safety sensitive position that may be subject to random drug testing, in accordance with applicable laws.
What The Controlled Substance Specialist Does Each Day
QuVa is a national, industry-leading provider of pharmacy services, including ready-to-administer sterile outsourcing and advanced AI-generated insights providing clarity for revenue capture and inventory management. QuVa Pharma delivers essential medications in injectable formats critical for effective patient care. LogicStream, a QuVa company, partners with health systems to aggregate, normalize, and analyze large amounts of complex data through AI and machine learning tools that generate actionable insights supporting revenue optimization, inventory management, and inventory-related workflows. Through QuVa’s integrated solutions, health systems can transform pharmacy management to achieve greater value by operating more efficiently and effectively as they deliver high-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.”
This is a full-time role for our 2nd shift, working Monday through Friday from 2:00 PM to 12:30 AM This is based on site in our Sugar Land, TX location. This is a safety sensitive position that may be subject to random drug testing, in accordance with applicable laws.
What The 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
- Have working knowledge of DEA regulatory requirements as well as all applicable SOPs.
- Communicate compliance requirements
- Influence and persuade peers on cross-functional teams, and resolve conflicts with peers
- Prioritize and plan work activities based upon priorities and criticality of issues
- Maintain attention to detail
- Demonstrate time-management skills
- Define performance goals and measure performance against the objectives.
- Effectively partner with cross-functional teams
- Associate degree
- Able to successfully complete a drug and background check
- 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
- Experience with ERP software
- Able and willing to walk, stoop, stand, bend, and lift up to 50 lbs. throughout each shift, with or without reasonable accommodation
- Must be currently authorized to work in the United States on a full-time basis; QuVa will not sponsor applicants for work visas
- Bachelor's degree
- INFOR Software experience
- 2-4 years’ experience in a regulated cGMP environment preferred
- 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
- Occasional weekend and overtime opportunities with advance notice
- National, industry-leading high growth company with future career advancement opportunities
QuVa is a national, industry-leading provider of pharmacy services, including ready-to-administer sterile outsourcing and advanced AI-generated insights providing clarity for revenue capture and inventory management. QuVa Pharma delivers essential medications in injectable formats critical for effective patient care. LogicStream, a QuVa company, partners with health systems to aggregate, normalize, and analyze large amounts of complex data through AI and machine learning tools that generate actionable insights supporting revenue optimization, inventory management, and inventory-related workflows. Through QuVa’s integrated solutions, health systems can transform pharmacy management to achieve greater value by operating more efficiently and effectively as they deliver high-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.”
