The Controlled Substance Specialist is responsible for
the coordination of regulatory documents involved with,
and managing all aspects of, the controlled substance
1. Provide access to the secure location storing
controlled substances and process all inventory
2. Prepare documentation to support site audits by the
Drug Enforcement Agency (DEA). Maintain audit
3. Create, complete and maintain material transfer
sheet for internal monitoring.
4. Manage the controlled substances area. Assure that
the area meets or exceed expectation for order and
5. Review customer 222 forms and generate 222 forms as
6. Perform due diligence on customer registration
7. Maintain appropriate labeling of incoming
8. Manage production quotas of controlled substances.
9. Manage the import and export of controlled
substances with the input of Business Development
and Materials Management functions.
10. Complete biannual inventory of the controlled
11. Complete ARCOS reporting to the DEA.
12. Prepare controlled substances for any necessary
destruction and complete the Form 41.
13. Assist in the 6S and Continuous Improvement
Programs in the production building.
14. Assist in material transfers and maintain
production inventory spreadsheets.
15. Recommend and implement methods to increase the
quality of products and/or service.
Office, especially with Excel.
- High school diploma or the equivalent.
- Extensive experience with and knowledge of Microsoft
management is a must.
- Working knowledge of MRP principles and materials
strict government regulations, specifically with the
- Prior experience with understanding and executing
DEA or FDA, is required.
to work independently and meet timelines.
- High degree of initiative with demonstrated ability
effectively with other departments.
- Demonstrated ability to communicate and coordinate
- Must have the ability to walk and stand for long
Albany Molecular Research Inc. (AMRI) is a global contract research and manufacturing organization that has been working with the Life...