Controlled Substance Quality Specialistf

McKesson•New York, NY

1d•$68,500 - $114,100•Remote

About The Position

McKesson is seeking a Controlled Substance Quality Specialist to join the U.S. Pharmaceutical Distribution (USPD) Quality Team. This role serves as an individual contributor responsible for the day-to-day management of the Theft and Loss program. Key duties include intake and evaluation of potential theft and loss cases within the Quality Management System (QMS) and Outlook mailbox, stakeholder follow-up, documentation, providing business guidance, and external reporting in accordance with internal procedures and regulatory requirements. The role also involves trend identification and analysis, support for external investigations, and ad-hoc reporting. This position leverages established procedures and decision trees to ensure accurate reporting of controlled substance and listed chemical theft and loss, thereby protecting the company. The ideal candidate will be detail-oriented, highly organized, a strong team player with excellent written and verbal communication skills, and possess sound judgment to escalate cases to senior leadership or Legal when necessary. This is a highly collaborative role that connects daily distribution operations, internal stakeholders, and external agencies through accurate documentation and reporting.

Requirements

Degree or equivalent and typically requires 2+ years of relevant experience.
2+ years with career progression in pharmaceutical distribution (operations, inventory, or support function), regulatory, support department, or similar regulated environment.
Detail-oriented, highly organized, and a strong team player.
Robust written and verbal communication skills across multiple levels.
Proficient in Microsoft: Outlook, Teams, Excel, Word.
Must be authorized to work in the US unrestricted.
Applicants must be currently authorized to work in the United States on a fulltime basis without the need for employer support or sponsorship now or in the future.

Nice To Haves

Preferred proficiency in: TrackWise or similar QMS, Acumax or similar WMS, SAP, MS Access, SharePoint.

Responsibilities

Monitor, intake, and process new theft and loss cases within the USPD QMS (TrackWise).
Initiate DEA INV within TrackWise and relevant email chains to stakeholders.
Review submitted documentation to determine key information for reporting decisions.
Follow-up with relevant stakeholders to obtain missing details or documentation.
Review impacted jurisdiction reporting requirements.
Send Initial Notification to external agencies as necessary.
Update DEA INV note field with case status and information.
Identify and escalate late DC reporting to the Controlled Substance Quality (CSQ) Senior Director.
Review existing pending cases and follow-up with relevant stakeholders.
Evaluate deadlines and escalate issues as necessary.
Maintain DEA INV notes field with updated information.
Complete external reporting or close-out cases with Closure Notification.
Validate that all relevant documents have been uploaded to TrackWise.
Complete DEA INV fields and notes field upon case closure.
Identify and analyze trends or patterns of risk related to theft and loss.
Identify opportunities for improvement at the DC level or within CSQ processes.
Provide reporting on theft and loss metrics upon request.
Provide documentation and details for external investigative demands, subpoena requests, and external inspections.
Collaborate and cross-train on ARCOS, Quality Audits, and various Quality functions.
Contribute to SOP content.
Complete special projects as assigned.
Complete all assigned training timely.