About the job
Controlled Substance Specialist
The Controlled Substance Specialist helps to ensure site DEA regulatory compliance for the Fagron Sterile Services West and East Facilities. This individual will assist with the development of processes and procedures that ensure DEA, and FDA cGMP compliance. This individual will help to ensure that all records are retained in a manner that they are easily retrievable and are complete in order to show inventory control and accountability. They will also assist with completing year-end inventories, inventory reconciliation, discrepancy investigations, and DEA Close of Business Reports & support or represent the business in matters of DEA investigations and audits.
- Assist with the implementation and maintenance of the Controlled Substance (CS) program, to include:
- Procedure development and creation
- Process development and implementation
- Assist with site gap assessments and development of action plans to ensure DEA & FDA cGMP compliance.
- Responsible for working though all CS inventory discrepancies to final resolution.
- Responsible for completing all CS inventory accountability and reconciliation activities.
- Support all DEA inspections, correspondence, and help ensure site readiness.
- Assist with submitting all appropriate CS documents to the DEA.
- Establishing a mechanism for documentation and tracking of all training regarding CS in order to ensure colleagues have completed their training on time and are current.
- Maintains all records and documentation records for CS.
- Assist with developing and growing a Security culture among all colleagues and contractors to ensure CS compliance
- Collaborates cross-functionally to gain alignment on compliance and quality issues.
- Develop procedures and handling reporting of all CS destruction activities.
- Responsible for handling all CS customer complaints including all samples returned to Fagron.
- Working to continuously improve our compliance profile in regards to the handling of CS.
- Represent the business on all DEA matters in the absence of the Controlled Substance Compliance Director through delegation of authority; e.g, vacations, out of office situations, etc.
Set yourself apart
You possess the following qualifications, background and abilities:
- Minimum of a Bachelor Degree in a scientific, engineering, or business discipline required. Advanced degree/certification preferred.
- Minimum 5 years of related working experience in a pharmaceutical or regulated industry is required.
- Experience working with standard ERP/MRP systems.
- Experience interpreting compliance requirements and regulations is required.
- Knowledge of DEA, FDA and state regulations pertaining to shipping controlled substances preferred.
- General knowledge of DEA requirements as they relate to distribution and product supply is preferred.
- Demonstrates skills to solve complex problems in a wide variety of high pressure situations which require a high degree of ingenuity, creativity and innovativeness. In situations where precedent may not exist, is able to independently exercise judgment, determine appropriate solution and take action.
- Demonstrates a strong ability to be adaptable and flexible.
- Demonstrates proven knowledge of business and management principles.
- Previous experience working with auditors, inspectors, and regulatory agencies.
- Previous experience operating under FDA cGMP with a robust understanding of the principles and applications associated with manufacturing operations.
What’s on offer?
Fagron offers exciting opportunities for personal and professional growth. We provide an open and truly dynamic environment which supports and encourages you to develop your skills and talents.