DEA /Training Coordinator

The DEA / Training Coordinator is accountable for all DEA quality system / reporting activities within the facility including the training program, internal auditing and compliance. The position will support other quality and compliance activities ensuring that Good Manufacturing Practices (GMP) are met and integration of their requirements into the quality systems at the facility. Also, responsible for overall site controlled substance program (e.g. such as, but not limited to controlled substance security, shipping/ receiving, storage, perpetual inventory, etc.). Executes DEA reporting activities: year-end inventories and reports, procurement quota, DEA 222 forms, and ARCOS reporting. The DEA Coordinator maintains Power of Attorney and State/Federal licenses for the site, serves as the site's DEA quality and compliance expert, and is responsible for DEA regulatory inspections. The employee 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, assists with controlled substance destruction process, performs daily controlled drug inventory, record keeping, reporting and accountability

Required Education:

• BS degree in science, technical or related fields.

Required Experience

• Minimum of 3 years of related experience in the Pharmaceutical Industry and DEA arena
• Understanding of DEA CFR 1300 to end.
• Knowledge of pharmaceutical quality systems with strong team building, logical reasoning, numerical, technical, leadership, and interpersonal skills
• Computer skills including Word, Excel & PowerPoint
• Good organizational program development skills
• Previous quality experience in pharmaceutical, transdermal DEA manufacturing environment with prior training in current Good Manufacturing Practices (cGMPs) practices and experience with DEA training
• Strong, verbal, written and interpersonal communication skills.
• Ability to work independently with good time management skills.

Scope and Responsibilities:

• Manage the controlled substance materials, maintain. monitor logs and records.
• Training of new hires to include by not limited to: New Hire, Initial cGMP, SOP, DEA.
• Development and training of an Annual cGMP program for all departments
• Oversee development and maintenance of training records, curriculum, status reports, and related training documentation
• Development and training of new programs
• Ability to develop training assessment tools to demonstrate training effectiveness
• Coordinate supplier qualification activities including supplier identification, selection, monitoring, and qualification
• Disposition raw materials based on careful scientific review of supplier documentation and internal data
• Participate in management and execution of the internal audit program compliance with all manufacturing processes in with all government agencies (cGMP, FDA, DEA, OSHA. EPA), DEA, filing and reporting.

We offer a competitive salary and benefits package.

Current Openings for DEA /Training Coordinator Jobs at Zydus Pharmaceuticals