Job Details
Job Type
Full-time
Description
**Experience with SAP in a warehouse environment is a requirement**
(this position is 100% on site in Chantilly, VA)
Job Summary
The Warehouse Manager will be an expert on all matters of the warehousing and DEA as it pertains to a pharmaceutical manufacturer and distributor of controlled substance. This position primarily responsible for the management of licenses, procurement, security controls, and movement of material, production, shipment, and destruction. This position should also have the ability to interface with governmental agencies and represent the company. This position also will ensure warehouse management and supervision of warehouse staff and maintain the compliance requirements as per 21 CFR part 210 and 211.
Principle Accountabilities
JOB DUTIES & RESPONSIBILITIES
Manage and coordinate all DEA related actives including security controls.
Review and update the security controls throughout the facility and security systems.
Issue, maintain and track all DEA 222 forms.
Coordinate all movement of control substances from purchase through analytical testing.
Prepare, review and revise SOPs and Policies pertaining to DEA activities.
Conduct Site wide training on controlled substance Standard Operating Procedures.
Manage import/export of control substance and complete necessary documentation.
Coordinate and maintain compliance of all DEA, State and Board of Pharmacy registrations.
Coordinate all controlled substance destruction.
Manage CII quotas and maintain organized DEA files on related activities.
Conduct yearly inventory and report ARCOS as per the company and DEA regulations.
Perform internal DEA audits for site and issue audit reports to management upon completion.
Review and implement procedures and controls to prevent diversion.
Perform and prepare investigation reports relating to DEA matters.
Remain current on DEA regulations in order to address organization business needs.
Manage Warehouse material receipt, supervising Dispensing and shipment in compliance with DEA and FDA.
OTHER or ADDITIONAL RESPONSIBILITIES
Experience in DEA compliance and Warehouse/QA experience within the pharmaceutical industry is highly preferred
Experience in writing and maintaining documentation.
Experience in security controls pertaining to DEA materials storage and manufacturing.
Ability to analyze data/information and to assess and resolve complex issues, as required.
Good verbal and written communication skills are required.
Ability to work and communicate with cross-functional teams.
Ability to manage multiple priorities and re-prioritize tasks, as required.
Flexible and able to adapt to company growth and evolving responsibilities.
Strong attention to detail and excellent organization
Management Responsibility
Responsible for all warehouse DEA for Granules. Planning, organizing, leading, and controlling.
Reports to
VP Operations
Requirements
Knowledge & Skills
- Measures essential skills of relevant job practices, policies, procedures, resources, laws, customer service and technical information.
- Experience with SAP in Warehouse Environment
- Experience in a cGMP regulated environment, pharma manufacturing preferred
Experience & Education- Minimum (3) to five (5) years of experience in a Warehouse Leadership role in a cGMP-regulated environment is required
- Experience in Pharmaceutical manufacturing is a plus.
- Bachelor's degree in a Natural Sciences (i.e., Biology, Chemistry), Pharmacy, or Engineering, or related area
Physical Requirements/Working EnvironmentThis position requires physical activity and heavy lifting at times.
Travel No travel required.