FAS Lab - Controlled Substance Compliance Associate

Fagron Sterile Services US (FSS); Wichita (KS); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

401(k) plan with company match

Medical, vision and dental

Health savings account (HSA)

Holiday/PTO

Job summary

Fagron Sterile Services US (FSS) is seeking a Controlled Substance Compliance Associate to own the daily logistics for controlled materials, ensuring DEA compliance and accurate documentation across all CS activities.

You will coordinate material movements, participate in inventory reconciliation, support API check-out, labeling, and reporting, and serve as a subject-matter expert to maintain a culture of compliance across the site.

Qualifications

• High School Diploma or equivalent required.
• Excellent time-management and ability to self-direct in managing concurrent requirements.
• Clear communication with colleagues, customers, suppliers in person, on the phone, and in writing.
• Excellent attention to detail and commitment to compliance with procedures.
• Proactive, problem-solving mindset with ownership of complex processes.
• Must meet all requirements for handling controlled substances.
• Familiarity with GDP principles in pharmaceutical environments; ERP tracking knowledge helpful.

Responsibilities

• Ensure correct and consistent CS material transactions: vault check-in/out, inventory reconciliation, sampling and disposal, and record-keeping.
• Support aseptic filling teams: API check-out/transfer, return check-in, consumption recording, line flush disposal.
• Track batch release status and material availability; manage deviations and delays.
• Coordinate with operations, post production, and labs for VI, labeling, testing, and validations.
• Conduct inventory reconciliation and dispose expired inventory.
• Maintain electronic inventory aligned with paper records and ensure data integrity.
• Assist CS Compliance in preparing monthly/quarterly reports (ARCOS).
• Act as SME to ensure DEA/site procedure compliance in daily activities.

Skills

Time management

Communication

Attention to detail

Problem solving

Ownership

GDP knowledge

ERP familiarity

Education

High School Diploma or equivalent

Tools

ERP system

Job description

This job was posted by https://www.kansasworks.com : For more information, please see: https://www.kansasworks.com/jobs/13645024

Who We Are

Since 1990, weve grown into a global leader in personalized medicine.

Today, our +5,000 energetic employees are based in +80 locations in Europe, North America, South America, Africa and Asia-Pacificand are working together to support over 200,000 customers worldwide.

From compounding and natural products to software, equipment, and genomics we deliver smart, ready-to-use solutions that make healthcare better.

Were passionate, science-driven, and always looking for new ways to improve lives.

Explore your future at Fagron Career Site.

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.
• ust 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, youll 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?

Were proud to be an equal opportunity employer. Diversity makes us stronger, and were 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 orientati