Manager, Drug Enforcement Administration (DEA)
Reporting to the Vice President, Quality and Regulatory Affairs, the Manager, DEA will have responsibility for managing, organizing, and coordinating the DEA Control Substance activities which support the Tedor Operations.
Under direction from, and in collaboration with, the Vice President, Quality and Regulatory Affairs, the DEA Manager will be responsible for:
• Assist warehouse staff with Controlled Substance GMP receiving of Controlled Raw Materials;
• Witness sampling of controlled substance materials for retains, R&D work, QC testing and clinical studies. File and maintain all inventory paperwork.
• Maintain Key Access and Vault Combination to DEA Controlled Access Areas. Track all employees with DEA access.
• Assist analytical laboratory with Receipt of samples and transfer of scheduled materials. Assist in managing DEA analytical laboratory inventory samples.
• Track and organize all DEA audit materials.
• Write and review DEA procedures.
• Assist Formulation/Production with placing the products formulated with controlled substances on stability/ chemical reserve/ manufacturing retains. Assist with transfer and tracking for these samples.
• File quarterly ARCOS and provide weekly update for ACROS tracking list.
• Update filed ACROS reports after receiving DEA correction Letters.
• Provide inventory of all items on the manufacturing license.
• Generate DEA controlled documents for Year-End reporting, based on received, filed and monitored production spreadsheets generated for reconciliation of every new made controlled batch of material.
• Track of all items on the DEA manufacturing license, items that have been transferred off, or sent to the packager, or packaged and placed on stability or manufacturing retain.
• File requests DEA Quota for CII materials.
• Order, track, maintain and submit DEA 222 forms for DEA Manufacturing and Analytical licenses.
• Manage DEA audits
• Organized a complete inventory of the Analytical license.
• Coordinate reverse distribution. Organize paperwork and prepare all the materials to be destroyed. Provide quarterly inventory updates.
• Working knowledge of DEA/GMP regulations and expectations
• Independently troubleshoots problems and issues; called upon to train, assist or supervise others for a large portion of the job
• Provides consistently prompt, efficient, dependable, highly skilled service
• Demonstrates consistent judgment, quality, accuracy, speed, and creativity
• Detects and resolves problems; assists others with problem resolution; misjudgment may jeopardize compliance.
• Takes initiative in making improvement suggestions to promote operational goals on a consistent basis.
• Recommend improvements to on-going processes and projects
• Implements and executes policies, practices, and compliance requirements
• Exercises discretion in referring complex issues and problems
• Good listening and communication skills
• Positive approach
• Proficient in the use of Microsoft Office
• College diploma with 1-2 years in pharmaceutical QA or Material Control environment is desirable.
• Knowledge of science generally attained through studies resulting in a B.S., in science, engineering, biochemistry or related discipline, or its equivalent is preferred.
• A minimum of 4 years of relevant experience in a regulated environment with at least 2 years focused on product quality.
• Knowledge of pharmaceutical quality manufacturing, packaging, and material handling, thorough knowledge of 21 CFR Parts 210, 211 and related guidance. Familiarity with 21CFR regulations regarding security, inventory