About the job
The Controlled Substance Compliance Specialist will support the DEA compliance profile by acting as one of the primary persons responsible for the logistics associated with the daily activities for all Controlled Substance Materials at Fagron Sterile Services.
Additionally, the Controlled Substance Compliance Specialist will serve as liaison to other functional areas within the FSS organization to support an overall culture of awareness and DEA compliance.
Responsibilities:
This individual will be responsible supervision of the controlled substance vault leads and controlled substance document specialist. In addition to being able to independently perform the tasks listed in the job descriptions for the controlled substance vault leads, associates, and specialist this individual will be responsible for the following:
- Assist with maintaining the Controlled Substance program, specifically responsible for the maintaining of controlled substance records and documentation.
- Assist with site gap assessment and development of action plans to ensure regulatory compliance with DEA, FDA (cGMP) and State Pharmacy Boards, ensuring site audit readiness for all DEA and regulatory inspections.
- Assist on submitting all appropriate documents to DEA and other regulatory agencies upon request.
- Collaborate with other department leads to gain alignment on compliance and quality issues.
- Includes collaboration with investigators to work through process deviations and customer complaints, as well as any associated corrective action plans.
- Support documentation life cycle (SOP, training material, batch records, perpetual inventory logs, etc.) as needed to maintain compliance and continuous improvement.
- Assist with the coordinating, documentation and reporting of activities relating to CS shipments, destruction and product returns.
- Responsible for assisting with CS inventory, including counting and reconciliation of counts and discrepancies.
- Support continuous improvement of site operations including developing and/or reporting of metrics relating to controlled substances.
- Assist in continued development and growth of a Security culture among all colleagues and contractors to help ensure CS compliance.
- Manage projects as deemed necessary by Controlled Substance Management.
Set yourself apart
Qualifications:
- High School Diploma or equivalent required.
- Must be able to meet all requirements for handling of controlled substances.
- Working knowledge of GDP principles as relating to a pharmaceutical manufacturing environment. Previous work experience in a regulated manufacturing industry a plus.
- Ability to communicate with colleagues, customers, suppliers, in person, on the phone, and by written communications in a clear, straightforward, and professional manner to clearly convey priorities and need.
- Excellent time-management skills and ability to self-direct in managing concurrent requirements.
- Proactive, problem-solving mindset – ability to identify and correct errors, offer improvement recommendations, and willingness to embrace ownership of complex process.
- Excellent attention to detail and commitment to maintaining consistency and compliance with established procedures.
- Familiarity with and/or willingness to learn ERP system tracking and management.
What’s on offer?
We offer a dynamic environment where talent and ambition can develop to its fullest. We have an open and informal organization culture, where individuals need to have strong motivation and ability to work independently. Fagron is a widely expanding, international, professional and ambitious pharmaceutical company with multiple growth opportunities. Job opportunity includes competitive salary, comprehensive benefits, performance package, and ability to be part of an international leader in an expanding industry.