The DEA Compliance Specialist III will ensure our Cincinnati site follows the Drug Enforcement Administration regulations 21 CFR Part 1300 to End, site policies, and Thermo Fisher Scientific Corporate policies in support of all controlled substance activities at the site. This position requires good communication, critical thinking, and problem solving skills. The DEA Compliance Specialist III works closely with manufacturing, development, lab personnel, and many other areas of the business that handle controlled substances.
What Will You Do?
Responsible to ensure compliance with Title 21 Code of Federal Regulations (Part 1300 to End) and corporate standard operating procedures regarding the manufacture, storage, and distribution of controlled substances through the completion of records and reports including DEA-222 Forms, ARCOS, Biennial Inventories, Quota Submissions, Computation Charts, and Year End Reports.
Acts as the site Controlled Substance Product Coordinator and SME for the site Controlled Substance Program. Responsible for implementation, maintenance, and ongoing compliance of group level policies and/or Corporate Controlled Substance Program policies.
Maintains knowledge of DEA regulations; monitors the Federal Register for changes in the regulations.
Assists management with DEA inspections, internal audits, client audits, investigations, inquiries and ensures coordination and follow-up of any identified CAPA's and actions.
Coordinates the receipt, storage, dispensing, shipment, and record keeping of controlled substances as it relates to Title 21 Code of Federal Regulations (Part 1300 to End).
Preparation, maintenance, shipping, and ordering of DEA 222 forms.
Facilitates the completion and submission of required DEA records and reports for controlled substances: ARCOS Reports, Year End Reports, Quota Submissions, and Import/Export submissions.
Conducts periodic internal audits of various departments for continuous improvement and to ensure regulatory compliance with 21 CFR (Part 1300 - End).
Builds or updates Standard Operating Procedures to reflect compliance with all vital regulations.
Develops and leads training programs related to DEA Compliance.
Able to prioritize duties and lead multiple projects, often cross-functional, from start to finish with minimal direction.
How Will You Get There
Education:
High School Diploma or GED Equivalent is required.
Bachelor's Degree from an accredited College or University in Chemistry, Biology, Microbiology or related field is helpful.
Experience:
3 Years experience in pharmaceutical manufacturing is preferred. Experience in DEA Compliance, Regulatory Affairs, Quality, and or Product Development is desired.
Knowledge, Skills, Abilities
Strong writing, interpersonal and verbal communication skills.
Must possess strong organization skills, time management skills and attention to detail.
Understanding of ERP's role in the business with regards to inventory management and reporting.
We provide a comprehensive compensation package, including salary, an annual incentive bonus plan, 401K with company match up to 6%, tuition reimbursement, and a range of other employee benefits! We cultivate an engaging company culture that promotes innovation, forward-thinking, and offers excellent career and development opportunities.
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