QA Specialist – DEA Compliance

Quality Seymour, Indiana


• Primarily responsible for oversight of DEA compliance and related activities in the Lannett – Seymour laboratories.

• Maintain Controlled Substances Perpetual Inventory Excel Spreadsheet
o Add new product codes for AR&D projects to DEA list in Perpetual Inventory
o Correct any sample weight or tablet count discrepancies
o Contact analysts to perform any necessary removal/return entries
o Copy sample history for drummed samples from Perpetual Inventory and paste into Sealed Perpetual Inventory excel spreadsheet. Remove drummed sample history from Perpetual Inventory.
• Maintain files for controlled substance tracking forms
• Coordinate with stability assistants on the removal and storage of completed stability study samples
• Coordinate DEA Year-End Inventory for Chemistry, AR&D and Analytical Services Departments
o Assemble a staff of at least 2 teams from each of the following areas:
 Chemistry Dept. (Raw Materials)
 Microbiology
 AR&D
 Analytical Services
 Chemistry
o Hold meetings to discuss the inventory plan, responsibilities, procedures and ensure everyone is properly trained on core DEA SOPs/QCLSs
o Contact all personnel with controlled substance combination/code privileges to ensure access
• Attend meetings held by QA DEA Activities
• Coordinate Destruction of QA released commercial products and AR&D released development projects
o Review controlled substance tracking forms for G-79 documentation compliance
o Create DEA calculator spreadsheets for all drummed samples
o File original DEA calculator spreadsheets
o Seal full drums and affix copies of calculator spreadsheets to drum exterior
o Notify QA DEA Activities of drums ready for destruction
o Submit all completed tracking forms to QA DEA Quality Assessor
• Routinely inspect controlled substance storage areas to determine if any samples/standards can have final inventory performed to alleviate space constraints.
o Remove any expired reference standards with the assistance of the reference standard coordinator
• Conduct all new employee training on department core DEA SOPs (DEA-12, DEA-13, QCLS-0022)
• Assist with the validation of excel spreadsheets
• Assist Reference Standard Coordinator with controlled substance standard initial placement
• Issue analysts laboratory notebooks and equipment logbooks
• Assist with the issuance of new and revised laboratory specifications and methods
• Assist with annual audit of laboratory specification and methods
• Assist QA DEA Activities Manager with controlled substance inventory searches
• Return completed complaint samples to respective QA Quality Associate
• Enter DEA Form 222 purchase order information into Controlled Substance Log
o File all DEA Form 222 copies 

• At least 5 years of experience in the pharmaceutical or related industry and knowledge of both FDA and DEA regulations is required
Bachelor’s Degree – Related scientific field

• Strong computer skills are required, with proficiency in the following application essential: MS Excel. Familiarity with other MS Office programs is a plus (Access, Word, PowerPoint).
• Strong attention to detail is critical in this role
• Must possess ability to prioritize, organize, and work effectively with minimal supervision. This includes strong follow-up skills, and the ability to provide timely closure of assigned tasks.
• Experience in reviewing technical documents / reports to assure compliance is a plus.
• Good interpersonal skills with ability to achieve consensus and cooperation with varying departments and personalities are preferred. Strong communication skills (both oral and written) for internal and external contacts are required.

(List the details of the environment within/under which work is performed and physical requirements for this position.)
• LIGHT - Exert up to 20 lbs. of force occasionally, and / or up to 10 lbs. of force frequently, and / or a negligible amount of force constantly to move objects. Physical demands are in excess of those of sedentary work. Light work usually requires walking or standing to a significant degree.
• Work is performed primarily indoors in an office or laboratory setting. The noise level in the work environment is low to moderate. Limited travel may be required.