- 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
- 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
- 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
- Experience in DEA Compliance or DEA related roles
- 2 to 3 years work experience with DEA / Controlled Substances
- 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
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DEA Compliance Specialist - Temple, United States - QuVa Pharma
Description
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:
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."
