FAS Lab- Controlled Substance Compliance Associate

Fagron Tech; Wichita, Northern (KS, KY); Hybrid; USD 55,000 - 75,000; Full time

Benefits offered by this job

401(k) plan with company match

Medical, vision and dental insurance

Health savings account (HSA)

Holiday/paid time off

Job summary

Fagron Sterile Services is seeking a Controlled Substance Compliance Associate to manage the daily logistics for Controlled Materials, ensuring DEA compliance and accurate documentation. The role acts as a liaison across functions to maintain a culture of awareness and regulatory adherence.

The position involves inventory reconciliation, sample inspection coordination, VI and labeling, and ongoing disposal of controlled substances, with a focus on accuracy and regulatory compliance in a GMP

Qualifications

• High School Diploma or equivalent required.
• 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 in a clear, straight-forward, and professional manner.
• Excellent attention to detail and commitment to maintaining consistency and compliance with established procedures.
• Proactive, problem-solving mindset and ownership of complex processes.
• Must be able to meet all requirements for handling of controlled substances.
• Familiarity with GDP principles and ERP tracking is preferred.

Responsibilities

• Accurately execute and document all CS material transactions: vault check-in/out, inventory reconciliation, sampling and disposal, finished product sales records.
• Support aseptic compounding and filling teams through API check-out/transfer and related intake/restocking activities.
• Monitor batch release status and manage raw material availability and inventory levels.
• Coordinate with operations, post production, and labs for support such as labeling, testing and validations.
• Perform inventory reconciliation and manage inventory disposal activities.
• Maintain electronic inventory records aligned with paper documentation.
• Monitor material accountability and obtain verification signatures as required.
• Assist CS Compliance Management with monthly/quarterly reports (e.g., ARCOS).
• Support site procedures to ensure DEA compliance and foster a security culture.

Skills

Time management

Clear communication

Attention to detail

Problem solving

DEA handling requirements

Education

High School Diploma or equivalent

Tools

ERP system

Job description

About the Job

The Controlled Substance Compliance Associate will support the DEA compliance profile by acting as the primary entity responsible for all the logistics associated with the daily activities for all Controlled Materials at Fagron Sterile Services.

This is a dedicated position that executes the logistics associated with raw material and finished product movements and required documentation, coordinates sample inspection and transfer, VI and labeling, inventory reconciliation and correct disposal.

Additionally, the Controlled Substance Compliance Associate will ensure that all CS-related activities occur in a consistent manner, and serve as liaison to other functional area within FSS in support of an overall culture of awareness and DEA compliance.

Key Responsibilities

• Correct and consistent execution and documentation of all CS material transactions: Vault check-in/out, inventory reconciliation, sampling and disposal, finished product sales record. Some example include: Perpetual Inventory Records, Reverse Distributor Manifest Forms (DEA Form 222 as applicable), Transfer Forms, Yearly Reconciliation Summary Forms.
• Support Aseptic Compounding and Filling teams throughout manufacturing process: API check-out and transfer (electronic inventory) to PROD IN, return check-in of API and finished product, recording of consumption, finished product unit and reject count verification, line flush disposal, etc.
• Track and communicate batch release status (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 as needed: VI and labeling, testing and method validations, etc.
• 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.

Basic Qualifications

• High School Diploma or equivalent required.
• 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 in a clear, straight-forward, and professional manner in order to clearly convey priorities and need.
• Excellent attention to detail and commitment to maintaining consistency and compliance with established procedures.
• Proactive, problem-solving mindset - ability to identify and correct errors, offer improvement recommendations, and willingness to embrace ownership of complex process.
• 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.
• Familiarity with and/or willingness to learn ERP system tracking and management.

What's on Offer?

Fagron offers its associates competitive salaries and a wide range of benefits including a 401(k) plan with a company matching contribution; medical, vision and dental; health savings account (HSA); holiday/paid time off.

At Fagron, you'll find plenty of chances to grow - both personally and professionally. We work in an open, dynamic environment where your ideas and talents can shine.

Ready for the challenge?

We're proud to be an equal opportunity employer. Diversity makes us stronger, and we're committed to creating an inclusive workplace where everyone feels welcome.

Fagron US is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law.