Controlled Substance Compliance Lead

3 weeks ago

Wichita, United States Fagron Sterile Services Full time
About the job
The Controlled Substance Compliance Lead 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 Lead will serve as liaison to other functional areas within the FSS organization to support an overall culture of awareness and DEA compliance.

Responsibilities:

•Planning and Managing- Developing a daily plan, delegating tasks to team, and ensuring that daily tasks are completed timely and accurately.

•Communicating- Relaying important information to shift associates and when necessary to controlled substance compliance management.

•Motivating- Creating a positive work environment and helping team members achieve organizational goals.

Additional Responsibilities:

• Support compounding and aseptic filling teams throughout manufacturing process. This includes but is not limited to transfer of API to and from the vault via Chain of Custody and ERP system, recording of API consumption, secondary unit count prior to relinquishing product to vault, review of and processing of batch record paperwork, verification of rejects, line flush disposal, etc.

•Support post-production team to execute visual inspection, tamper sealing, labeling and bagging activities. This includes but is not limited to pulling of product totes from vault for execution of above-mentioned activities, completing the documentation required for each transfer to and from the vault, secondary product count when product is returned to vault.

•Support FSS Labs as needed regarding testing and method validations for controlled substances. This includes but is not limited to extracting and transferring samples of API for ID testing, pulling, and transferring finished product samples for final quality testing, storing, and transferring lab batch and reference standard containers to chem/micro labs when requested.

•Support batch release and customer service teams by verifying and scrapping rejects and moving inventory to sellable locations in-order to process sales orders. Subsequently to release, vault associate will assist in pulling released product to fulfil sales orders and transfer to post-production staff for shipping.

•Ensure that all rejected materials are documented and destroyed appropriately. This may require communication with outside reverse distributors. Destruction includes rejected units from operations as well as liquid waste from operations and FSS labs.

•Correctly and consistently completing all required documentation for all above-mentioned controlled substance transactions. Form examples include Perpetual Inventory Records, Controlled substance Disposal Logs, Chain of Custody Forms.

•Assist team with routine inventory counts and reconciliation as often as and outlined in standard operating procedures.

•Ensure that product count aligns with official paper record (Perpetual log) as well as electronically (ERP system) upon completion of post-production activities, prior to release of product and over the course of sales transactions.

•Continuous monitoring of material accountability records for errors, completions of review and verification signatures.

•Clerical tasks including data entry, scanning, organizing, and storing of controlled documents.

•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

Set yourself apart
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, straightforward, and professional manner 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?
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.

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