- Prepare DEA reporting activities to include: year–end inventories, procurement quota’s, ARCOS reporting, tracking of DEA 222’s (Schedule I and II)
- Assist Sr. DEA Specialist with the Quality, Operations, and Engineering, Warehousing, and Sales personnel to address DEA compliance activities at all sites
- Assist with DEA regulatory inspections at all company sites (U.S.A)
- Maintains Power of Attorney and State/Federal licenses for all company sites (U.S.A)
- Adheres to all company SOPs and policies
- Maintains drug code and scheduling modifications to registrations
- Supports vendor and customer DEA registrations
- Leads and/or assists with controlled drug internal audits, inspections and inquiries
- Prepare Import/Export documentation for all company Analytical and Manufacturer sites
- Assists with controlled substance destruction process
- Performs daily controlled drug inventory, recordkeeping, reporting and accountability
- Track new employee DEA criminal backgrounds
- 20% Travel to sister sites in the U.S.A
- Other duties as assigned
- BS degree in science, technical or related fields with a minimum of 3 years of related experience in the Pharmaceutical Industry and DEA arena (from cradle to grave)
- Strong written and verbal communication skills
- Excellent detail skills as they apply to documentation review and compliance
- Good mathematical skills (i.e., unit of measure conversions for DEA reporting functions)
- Knowledge of Microsoft Office Suite and Excel
- Ability to influence others work
- Familiar with cGMP
- Knowledgeable with CFR 1300 to End
- Familiar with DEA State regulations
- The position reports to Sr. Director, Drug Product Operations.
- This position has no supervisory responsibility.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Less than one third of the time is spent sitting.
- Between one third and two thirds of the time is spent standing.
- Less than one third of the time is spent lifting up to 25 pounds
Environment and Protective Equipment:
- None – working in an office
- Will require interaction with production and lab environments during audits and investigations
What we offer you:
- Profit sharing bonus plan
- Medical, dental and vision coverage from day one
- A menu of voluntary benefits including short & long term disability, life, accident, critical illness and hospital indemnity insurances
- Paid/flexible sick-leave, vacations, and holidays so you can take the time when you need it
- To complement your personal financial strategy, we also have 401(k) matching
- We offer competitive salary, a comprehensive benefits package and advancement opportunity.
- Our company is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.