Quva Pharma Temple , TX 76502
Posted 3 weeks ago
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
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:
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 Pharma is a national, industry-leading, FDA registered 503B outsourcing services company that provides hospitals with essential medications in ready-to-administer injectable formats that are critical for effective patient care. We are leading the way with unmatched expertise in current Good Manufacturing Practices and sterile pharmaceutical manufacturing, and the highest quality and safety standards so hospitals can more confidently and reliably focus on patient care nationwide. As a leader in sterile compounding, we continue to invest in automation and integrated technologies to improve our production processes, safety, consistency, and product quality.
As part of our team, you'll experience being at the forefront of groundbreaking solutions, collaborating with brilliant minds, and making a tangible impact in healthcare delivery.
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."
Quva Pharma