[Hiring] Quality Specialist @McKesson

Role Description

The Quality Specialist supports the day-to-day quality work for US Pharmaceutical Distribution. This includes:

• Reviewing temperature excursions
• Completing product quality investigations
• Supporting corrective and preventive actions (CAPA)
• Helping with recalls and quality system activities

The role works within established procedures and uses good judgment to complete assigned work, make recommendations, and raise higher-risk or unfamiliar issues when needed.

Key Responsibilities

• Reviews and documents routine to moderately complex temperature excursions, product quality issues, investigations, CAPAs, and critical events. Follows established procedures and raises significant risks or unusual issues promptly.
• Creates and maintains accurate records in the electronic quality management system. Supports approved process and system changes and helps ensure new requirements are put into practice.
• Collects and reviews investigation data, metrics, and trends. Identifies possible issues and recommends follow-up actions for review.
• Works with Operations, Compliance, distribution centers, Technology, and outside partners to complete assigned activities on time. Keeps the right people informed and follows up on open items.
• Applies relevant FDA requirements, 21 CFR, the Drug Supply Chain Security Act, United States Pharmacopeia standards, Good Distribution Practice, current Good Manufacturing Practice, and internal procedures to assigned work. Helps prepare for audits and inspections.
• Writes clear and complete investigation records, reports, and communications.
• Ensures required information is entered in the appropriate system on time.
• Participates in training, team discussions, and improvement activities.
• Shares lessons learned and helps promote consistent quality practices.

Qualifications

• Bachelor's degree in science, engineering, pharmacy, quality, or a related field, or equivalent experience.
• 4+ years of experience in pharmaceutical quality, investigations, CAPA, recalls, regulated distribution, cold-chain operations, quality systems, or a similar regulated environment.

Requirements

• Experience applying quality procedures to routine and moderately complex issues and knowing when additional guidance is needed.
• Ability to organize work, manage priorities, meet deadlines, and complete assignments with general supervision.
• Good attention to detail and a consistent approach to accurate, timely, and compliant documentation.
• Ability to review information, recognize possible risks, and make practical recommendations within established guidelines.
• Clear written and verbal communication skills and the ability to work effectively with colleagues in different functions.
• Working knowledge of applicable FDA regulations, 21 CFR, the Drug Supply Chain Security Act, Good Distribution Practice, current Good Manufacturing Practice, investigations, root cause analysis, CAPA, quality risk management, and data integrity.
• Experience with electronic quality management systems, Microsoft Office applications, quality data, and technical documentation.
• Ability to work primarily from a remote location and collaborate regularly with distribution center personnel, cross-functional teams, and corporate partners.
• Ability to occasionally work in a distribution center, operational, or warehouse environment to support investigations, audits, and quality activities.
• Ability to travel domestically, including occasional overnight travel, up to 10%.
• Ability to work for extended periods at a computer and review detailed electronic records, data, and quality documentation.

Benefits

• Competitive compensation package including a base pay range of $83,300 - $138,800.
• Annual bonus or long-term incentive opportunities may be offered.