FAS Lab - Controlled Substance Compliance Associate

This job was posted by https://www.kansasworks.com : For more

information, please see: https://www.kansasworks.com/jobs/13602406

## 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](https://fagron.jobsmarket.site/pages/en-gb/jobs).

## 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 proce s.

• 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, 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.

## Read