Job Overview
Employment Type
Full-time
Benefits
Health Insurance
Dental Insurance
Paid Time Off
Retirement Plan
Professional Development
Job Description
Fagron Sterile Services is a specialized pharmaceutical manufacturing company that focuses on providing sterile compounding solutions and services to healthcare providers and pharmacies. Dedicated to maintaining the highest standards of quality and regulatory compliance, Fagron Sterile Services operates within a heavily regulated industry that demands meticulous attention to detail, especially in the handling and management of controlled substances. The company prides itself on fostering a culture of safety, security, and compliance, ensuring that all aspects of its manufacturing and operational processes align strictly with regulatory requirements such as those set forth by the Drug Enforcement Administration (DEA) and Good Distribution Practice (GDP) principles. Their commitment to excellence and continual improvement has established them as a trusted partner within the pharmaceutical supply chain.
The role of Controlled Substance Compliance Associate at Fagron Sterile Services is a vital position dedicated to supporting the company’s DEA compliance profile. This full-time role is centered on ensuring the accurate and consistent execution of all logistics associated with controlled materials, including raw materials and finished products. The associate acts as the primary entity responsible for managing the daily activities involving controlled substances within the organization. Key responsibilities include the coordination of inventory reconciliations, sample inspections and transfers, verification and labeling of materials, as well as the correct disposal of expired or unusable products. This position requires rigorous documentation and record-keeping to maintain alignment between electronic inventory systems and official paper records.
Beyond transactional duties, the Controlled Substance Compliance Associate serves as a critical liaison to other functional areas within Fagron Sterile Services, promoting a culture of DEA awareness and compliance company-wide. The role supports aseptic compounding and filling teams throughout the manufacturing process by handling check-in/check-out procedures, tracking batch release statuses, and facilitating communication across operations, post-production, and lab teams to ensure smooth coordination of activities related to controlled substances. This position demands a proactive, detail-oriented individual with exceptional time-management skills and the ability to independently manage complex, concurrent tasks. The associate will also assist compliance management with preparing and submitting regulatory reports, further ensuring that Fagron Sterile Services remains compliant with federal and industry regulations.
Overall, this role is suited for candidates who possess a strong commitment to regulatory compliance, possess the ability to manage sensitive and critical materials securely, and have the communication skills to effectively interact with various stakeholders. Familiarity with ERP systems and experience in a regulated manufacturing environment is highly desirable, although willingness to learn is equally valued. Joining Fagron Sterile Services as a Controlled Substance Compliance Associate means contributing to a safety-focused culture that upholds both company standards and regulatory mandates in every aspect of its operations.
The role of Controlled Substance Compliance Associate at Fagron Sterile Services is a vital position dedicated to supporting the company’s DEA compliance profile. This full-time role is centered on ensuring the accurate and consistent execution of all logistics associated with controlled materials, including raw materials and finished products. The associate acts as the primary entity responsible for managing the daily activities involving controlled substances within the organization. Key responsibilities include the coordination of inventory reconciliations, sample inspections and transfers, verification and labeling of materials, as well as the correct disposal of expired or unusable products. This position requires rigorous documentation and record-keeping to maintain alignment between electronic inventory systems and official paper records.
Beyond transactional duties, the Controlled Substance Compliance Associate serves as a critical liaison to other functional areas within Fagron Sterile Services, promoting a culture of DEA awareness and compliance company-wide. The role supports aseptic compounding and filling teams throughout the manufacturing process by handling check-in/check-out procedures, tracking batch release statuses, and facilitating communication across operations, post-production, and lab teams to ensure smooth coordination of activities related to controlled substances. This position demands a proactive, detail-oriented individual with exceptional time-management skills and the ability to independently manage complex, concurrent tasks. The associate will also assist compliance management with preparing and submitting regulatory reports, further ensuring that Fagron Sterile Services remains compliant with federal and industry regulations.
Overall, this role is suited for candidates who possess a strong commitment to regulatory compliance, possess the ability to manage sensitive and critical materials securely, and have the communication skills to effectively interact with various stakeholders. Familiarity with ERP systems and experience in a regulated manufacturing environment is highly desirable, although willingness to learn is equally valued. Joining Fagron Sterile Services as a Controlled Substance Compliance Associate means contributing to a safety-focused culture that upholds both company standards and regulatory mandates in every aspect of its operations.
Job Requirements
- High school diploma or equivalent
- Excellent time-management skills and ability to self-direct in managing concurrent requirements
- Ability to communicate with colleagues, customers, suppliers in person, on the phone, and by written communications clearly, straight-forwardly, and professionally
- Excellent attention to detail and commitment to maintaining consistency and compliance with established procedures
- Proactive, problem-solving mindset with ability to identify and correct errors, offer improvement recommendations, and willingness to embrace ownership of complex processes
- Must be able to meet all requirements for handling of controlled substances
- Working knowledge of GDP principles relating to a pharmaceutical manufacturing environment
- Previous work experience in a regulated manufacturing industry a plus
- Familiarity with and/or willingness to learn ERP system tracking and management
Job Qualifications
- High school diploma or equivalent
- Excellent time-management skills and ability to self-direct in managing concurrent requirements
- Ability to communicate with colleagues, customers, suppliers in person, on the phone, and by written communications clearly, straight-forwardly, and professionally
- Excellent attention to detail and commitment to maintaining consistency and compliance with established procedures
- Proactive, problem-solving mindset with ability to identify and correct errors, offer improvement recommendations, and willingness to embrace ownership of complex processes
- Must be able to meet all requirements for handling of controlled substances
- Working knowledge of GDP principles relating to a pharmaceutical manufacturing environment
- Familiarity with and/or willingness to learn ERP system tracking and management
- Previous work experience in a regulated manufacturing industry a plus
Job Duties
- Correct and consistent execution and documentation of all CS material transactions including vault check-in/out, inventory reconciliation, sampling and disposal, finished product sales record
- Support aseptic compounding and filling teams throughout manufacturing process including API check-out and transfer, return check-in of API and finished product, recording of consumption, finished product unit and reject count verification, line flush disposal
- Track and communicate batch release status including delays due to deviations/unplanned events, raw material availability and inventory levels
- Communicate with operations, post production, and FSS Labs as needed to request support such as VI and labeling, testing and method validations
- Execute all inventory reconciliation and expire inventory disposal activities
- Maintain current electronic inventory in alignment with official paper record
- Continuous monitoring of material accountability records for errors, completions of review and verification signatures
- Assist CS compliance management in preparing and submitting monthly/quarterly reports (i.e. ARCOS)
- Support operations by acting as SME in ensuring DEA and site procedure compliance for all daily activities
- Assist with development and growth of a security culture among all colleagues and contractors to help ensure CS compliance
Job Criteria
Experience
No experience required
Job Location
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