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Controlled Substance Quality Specialistf
McKesson
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About this role
McKesson is an impact-driven, Fortune 10 company that touches virtually every aspect of healthcare. We are known for delivering insights, products, and services that make quality care more accessible and affordable. Here, we focus on the health, happiness, and well-being of you and those we serve – we care.
What you do at McKesson matters. We foster a culture where you can grow, make an impact, and are empowered to bring new ideas. Together, we thrive as we shape the future of health for patients, our communities, and our people. If you want to be part of tomorrow’s health today, we want to hear from you.
Company Profile
McKesson Corporation is a global leader in healthcare supply chain management solutions, retail pharmacy, community oncology and specialty care, and healthcare information solutions. McKesson partners with pharmaceutical manufacturers, providers, pharmacies, governments, and other organizations in healthcare to help provide the right medicines, medical products, and healthcare services to the right patients at the right time, safely and cost-effectively.
United by our I2CARE shared principles, our employees work every day to innovate and deliver opportunities that make our customers and partners more successful - all for the better health of patients. McKesson has been named a “ Most Admired Company ” in the healthcare wholesaler category by FORTUNE, a “ Best Place to Work ” by the Human Rights Campaign Foundation, and a top military-friendly company by Military Friendly. For more info, visit www.mckesson.com .
We take pride in our culture of connection and believe in a workplace where everyone can be their full, authentic self. We welcome and encourage veterans, individuals with disabilities and others with diverse perspectives to join our growing team. Your unique perspective and experience are valuable assets that can translate into a rewarding career path with us.
Position Description
McKesson 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 Requirement Degree 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 Micr
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