Controlled Substance Specialist

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 fulltime role working Monday through Friday from 4:00 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 crossfunctional relationships with peers in other departments including Quality Manufacturing Operations Supply Chain and Pharmacy Services to meet plant objectives
• Completes inprocess 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 noncompliant 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 crossfunctional teams to review operational performance and drive improvement through the initiation and 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 Specialists:

• Have working knowledge of DEA regulatory requirements as well as all applicable SOPs.
• Communicate compliance requirements
• Influence and persuade peers on crossfunctional teams and resolve conflicts with peers
• Prioritize and plan work activities based upon priorities and criticality of issues
• Maintain attention to detail
• Demonstrate timemanagement skills
• Define performance goals and measure performance against the objectives.
• Effectively partner with crossfunctional teams

Minimum Requirements for this Role:

• Associate degree
• Able to successfully complete a drug and background check
• 12 years relevant experience to include Project Management operations regulatory compliance and/or pharmaceutical experience
• 12 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 fulltime basis; QuVa will not sponsor applicants for work visas

Any of the Following Will Give You an Edge:

• Bachelors degree
• INFOR Software experience
• 24 years experience in a regulated cGMP environment preferred

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
• Occasional weekend and overtime opportunities with advance notice
• National industryleading high growth company with future career advancement opportunities

About QuVa:

QuVa is a national industryleading provider of pharmacy services including readytoadminister sterile outsourcing and advanced AIgenerated 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 inventoryrelated workflows. Through QuVas integrated solutions health systems can transform pharmacy management to achieve greater value by operating more efficiently and effectively as they deliver highquality 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.

Required Experience:

Unclear Seniority