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Quva · 15 hours ago

DEA Compliance Specialist

Sugar Land, TX

Full-time

Onsite

Senior Level

5+ years exp

Quva is a company that provides industry-leading health-system pharmacy services and solutions. They are seeking a DEA Compliance Specialist to manage and coordinate all DEA related activities at the manufacturing site, ensuring compliance with regulations and maintaining the quality and safety standards of pharmaceutical products.

Health CareManufacturingMedicalMedical DevicePharmaceutical

Comp. & Benefits

No H1B

Responsibilities

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

Qualification

DEA compliance expertiseDEA manufacturing regulationsDrug quota managementCompliance systems implementationControlled substances knowledgeCommunication skillsDetail-orientedSelf-starter

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

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

Preferred

Experience in DEA Compliance or DEA related roles

2 to 3 years work experience with DEA / Controlled Substances

Benefits

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

Company

Quva

Quva is a national, industry-leading provider of health-system pharmacy services and solutions, including 503B sterile injectable outsourcing and data software solutions that generate insights to help power the business of pharmacy.

Founded in 2015

Sugar Land, Texas, USA

1001-5000 employees