Our DEA Compliance Specialist plays a vital role in ensuring the highest quality and safety standards of our pharmaceutical products. Once you complete our training, your responsibilities will include managing and coordinating all DEA related activities at the manufacturing site. This person is a subject matter expert on all matters related to DEA compliance in pharmaceutical manufacturing industry, to include the distributing of controlled substances. Your attention to detail and adherence to precise procedures will guarantee that our medications meet the highest standards of safety, efficacy, and quality, providing patients with the best possible care and outcomes. Turn your passion for precision and your commitment to quality into a meaningful impact on healthcare across the US.
What the DEA Compliance Specialist Does Each Day:
- Manages and coordinates all DEA related activities at multiple production facilities
- Conducts year end and biennial inventory and report ARCOS quarterly reporting and cycle count inventory via DEA website
- Responsible for implementing and gathering data to support YERS inventories
- Coordinates all movement of control substances from manufacturing through analytical testing
- Trains internal individuals on controlled substance Standard Operating Procedures
- Maintains compliance of all DEA, State and Board of Pharmacy registrations
- Coordinates all controlled substance destruction with appropriate Quality and Logistics departments
- Responsible for all necessary DEA registration and ordering forms (DEA 222)
- Responsible for regulatory requirements for CSOS setup and maintenance
- Responsible for submitting CII quotas to DEA, maintain organized DEA files on related activities
- Coordinates and document DEA audits for sites and issue audit reports to management upon completion
- Remains current on DEA regulations in order to address organization business needs
Our Most Successful DEA Compliance Specialists:
- Are detail-oriented with strong verbal and written communications skills
- Express energy, show accountability, and multi-task
- Fulfill expectations, establish sustainable relationships with team members, maintain effective and meaningful communication channels
- Have a sense of urgency, accountability, and resourcefulness
- Are self-starters and independent learners
Minimum Requirements for this Role:
- Bachelor’s degree or equivalent with 5 to 7 years work experience
- Able to successfully complete a drug and background check
- Expert in DEA manufacturing regulations and requirements
- Experience in maintaining DEA compliance systems
- Knowledgeable in drug quota management and submissions
- Experienced in the workings of the department of justice and DEA for communications
- Implementing compliance systems to maintain corporate compliance of all DEA regulations
- Knowledge in the security requirements
- 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
Any of the Following Will Give You an Edge:
- Experience in DEA Compliance or DEA related roles
- 2 to 3 years work experience with DEA / Controlled Substances
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, 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.”
Equal Opportunity EmployerThis employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.
Skills Required
- Bachelor's degree or equivalent with 5 to 7 years work experience
- Able to successfully complete a drug and background check
- Expert in DEA manufacturing regulations and requirements
- Experience in maintaining DEA compliance systems
- Knowledgeable in drug quota management and submissions
- Experience in communications with Department of Justice and DEA
- Experience implementing compliance systems for DEA regulations
- Knowledge of security requirements for controlled substances
- Able and willing to walk, stoop, stand, bend, and lift up to 50 lbs throughout each shift
- Must be currently authorized to work in the United States full-time; employer will not sponsor work visas
- Experience in DEA compliance or DEA-related roles (gives an edge)
- 2 to 3 years work experience specifically with DEA / Controlled Substances (gives an edge)
What We Do
QuVa Pharma is a leader in 503B outsourced compounding, serving all 50 states with a full portfolio of sterile, ready-to-administer injectable products. QuVa was purpose-built to change the 503B industry for the better and is leading the way in making it more safe, efficient, and reliable. With unmatched expertise in cGMPs and sterile pharmaceutical manufacturing, we achieve higher than required quality and safety standards and maintain a leading FDA compliance record, so hospitals can more confidently and reliably focus on patient care. While our leading cGMP processes, sterile-to-sterile portfolio, and expansive capacity of 300,000 sq ft across four facilities are the foundation of success, it is our transparency, customer-focused service, and contracted supply arrangements that enable us to help hospitals and health systems better meet their patient care and operational needs. As FDA compliance becomes more stringent, QuVa's ability to reliably supply the highest-quality products is more valuable than ever and allows hospitals to spend more time on patient care and less time worried about beyond use dates, waste, workload inefficiencies, and compliance. That is why QuVa is proud to be recognized as the partner of choice for many of the nation’s leading health systems. So, whether you are calling for a response or being called on for a solution, know that QuVa is accountable, and in us, you always have an answer.
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