Onsite Quality Operations Specialist, Pharma Distribution

McKesson; Lakeland (FL); On-site; USD 100,000 - 105,000; Full time

Job summary

McKesson in Lakeland, FL is seeking a Quality Operations Specialist to join the USPD Quality Team. You will provide quality guidance to Operations, drive continuous improvement, and support the QMS across the network in a fast-paced, regulated environment.

The role requires 4+ years in pharmaceutical quality, knowledge of cGMP/DSCSA, and strong cross-functional collaboration. This onsite position offers opportunities to influence inspections, CAPA processes, and regulatory readiness.

Qualifications

• Degree or equivalent and typically requires 4+ years of relevant experience.
• Knowledge of cGMPs and Good Distribution Practices with a minimum of 2 years in a Quality Assurance role.
• Experience in a large, matrixed organization with cross-functional exposure to Quality, Operations, Compliance, Technology, and external partners.
• Strong communication and judgment skills.

Responsibilities

• Serve as the primary Quality liaison to Operations at the Lakeland DC
• Maintain a regular onsite presence to foster a culture of quality, compliance, and collaboration
• Partner with cross-functional stakeholders to address operational quality needs and risks
• Promptly escalate critical events while planning the investigative approach based on event risk, urgency, resource availability, and potential business impact
• Oversees critical investigation execution, coordinating cross-functional input as needed to support timely and effective resolution
• Create, review and/or edit SOPs and WIs to enhance operational efficiency and compliance
• Ensure operational compliance with DSCSA and implementation of National Standards
• Supports investigations, coaching teams on root cause analysis tools, and CAPA development
• Translates data into actionable recommendations to improve investigation outcomes and inspection readiness

Skills

Quality Systems

Regulatory Knowledge

Cross-functional Collaboration

Investigations & CAPA

Communication

Analytical Thinking

Education

Bachelor's degree in science/quality

Equivalent experience considered

Tools

TrackWise

MasterControl

eQMS

Job description

McKesson in Lakeland, FL is seeking a Quality Operations Specialist to join the USPD Quality Team. You will provide quality guidance to Operations, drive continuous improvement, and support the QMS across the network in a fast-paced, regulated environment.

The role requires 4+ years in pharmaceutical quality, knowledge of cGMP/DSCSA, and strong cross-functional collaboration. This onsite position offers opportunities to influence inspections, CAPA processes, and regulatory readiness.