Position DescriptionMcKesson is seeking a
Controlled Substance Quality Specialist.
The Controlled Substance Quality Specialist will serve as an individual contributor within the U.S. Pharmaceutical Distribution (USPD) Quality Team, providing day-to-day coverage of the Theft and Loss program. The responsibilities include the intake and evaluation of DC potential theft and loss cases within USPD Quality's Quality Management System (QMS) and shared Outlook mailbox, stakeholder follow-up, documentation, business guidance, and external reporting (in accordance with internal procedures and applicable regulatory requirements). Secondary responsibilities will include trend identification and analysis, external investigation support, and ad-hoc reporting.
This role leverages existing robust procedures, decision trees, and established precedence to protect the company in accurately reporting the theft and loss of controlled substances and listed chemicals. This individual will need to be detail oriented, highly organized, and a strong team player with robust written and verbal communication skills.
This role also requires sound judgement to escalate cases or scenarios to senior leadership or the Legal department when risk or trends are identified, new precedence for reporting will be set, or assistance is needed with DC stakeholders. This is a highly collaborative role that bridges the gap between daily distribution operations, internal stakeholders, and external agencies that rely on accurate documentation and reporting.
This is a remote (work from home) role within the continental United States (PST, MST, CST, or EST).
Key Responsibilities Complete Case Identification and Management- Monitor, intake, and process new cases within the USPD QMS (TrackWise).
- Initiate DEA INV within TrackWise, initiate email chain to relevant stakeholders, review submitted documentation to determine what key information is needed for a reporting decision.
- 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.
- Identify and late DC reporting and escalate to Controlled Substance Quality (CSQ) Senior Director.
Manage Case Tracking and Follow-Up- Review existing cases that are pending additional information and follow-up with relevant stakeholders.
- Continue to evaluate deadlines and escalate, as necessary.
- Maintain DEA INV notes field with updated information.
Complete Case Closure and External Reporting- Complete external reporting or close-out cases with Closure Notification, as necessary.
- Validate all relevant documents have been uploaded to TrackWise.
- Complete DEA INV fields and notes field.
Identify Trends, Risk, Opportunities for Improvement- Identify and analyze trends or patterns of risk.
- Identify opportunities for improvement at the DC level or within CSQ processes.
Complete Ad-Hoc Reporting and Requests for Investigative Demands- Upon request, provide reporting on theft and loss metrics.
- Provide documentation and details for external investigative demands related to theft and loss, subpoena requests, and external inspections.
Collaborate and Cross-Train on CSQ and Quality Functions- Once established in role, continue growing by learning about ARCOS, Quality Audits, and various Quality functions to expand knowledge and support the team when needed.
- Contribute to SOP content.
- Special projects as assigned.
- Complete all assigned training timely.
Minimum RequirementDegree or equivalent and typically requires 2+ years of relevant experience.
Critical Skills- 2+ years with career progression in pharmaceutical distribution (operations, inventory, or support function), regulatory, support department, or similar regulated environment.
- Skills: detail-oriented, highly organized, and a strong team player with robust written and verbal communication skills across multiple levels.
- Proficient in Microsoft: Outlook, Teams, Excel, Word.
- Preferred proficiency in: TrackWise or similar QMS, Acumax or similar WMS, SAP, MS Access, SharePoint.
Work Environment- Set up for Work from Home or proximity to a McKesson USPD distribution center.
- Interaction with internal and external stakeholders via Teams or phone.
- Robust internet and power connection.
- Domestic travel up to 5% of the year.
- Must be authorized to work in the US unrestricted - This position is not eligible for sponsorship. McKesson complies with all applicable U.S. immigration laws and regulations. The Company does not provide employer support or sponsorship for any immigration related employment benefit for this role. 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. This includes having the legal right to work in the United States without the need for McKesson support or sponsorship for any immigration related employment authorization (e.g., H1B, O1, E3, H1B1, TN, F1 OPT, F1 STEM OPT, F1 CPT, etc.) now or in the future. If you will require McKesson to provide immigration support or sponsorship now or in the future, you should not apply for this position.
We are proud to offer a competitive compensation package at McKesson as part of our Total Rewards. This is determined by several factors, including performance, experience and skills, equity, regular job market evaluations, and geographical markets. The pay range shown below is aligned with McKesson's pay philosophy, and pay will always be compliant with any applicable regulations. In addition to base pay, other compensation, such as an annual bonus or long-term incentive opportunities may be offered. For more information regarding benefits at McKesson, please click here.
Our Base Pay Range for this position$68,500 - $114,100
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