Quality Specialist

🔥 13 hours ago

🏖️ New Jersey, Pennsylvania – Remote

🏖️ New Jersey – Remote 🔔 Pennsylvania – Remote

💵 $110k - $112k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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McKesson

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1833

💼 Consulting

📦 Logistics

🏥 Healthcare

Consulting • Logistics • Healthcare

McKesson is a diversified healthcare leader specializing in pharmaceutical distribution, medical supplies, and healthcare services. Their solutions facilitate patients' access to life-changing therapies, support efficient operations for pharmacies, health systems, and clinics, and address critical issues such as drug shortages through a resilient supply chain. McKesson provides comprehensive services such as pharmacy management software, consulting, and technology solutions for specialty practices, focusing on improving health outcomes and advancing the pharmaceutical industry. They work closely with biopharma companies to enhance medication access, adherence, and commercialization while supporting oncology and biopharma practices through data-driven insights and real-world evidence.

📋 Description

• Support day-to-day quality work for US Pharmaceutical Distribution • Review and document routine to moderately complex temperature excursions, product quality issues, investigations, CAPAs, and critical events • Raise significant risks or unusual issues promptly • Create and maintain accurate records in the electronic quality management system • Support approved process and system changes and help implement new requirements • Collect and review investigation data, metrics, and trends • Identify possible issues and recommend follow-up actions • Work with Operations, Compliance, distribution centers, Technology, and outside partners to complete assigned activities • Keep stakeholders informed and follow up on open items • Apply FDA requirements, 21 CFR, the Drug Supply Chain Security Act, United States Pharmacopeia standards, Good Distribution Practice, current Good Manufacturing Practice, and internal procedures • Help prepare for audits and inspections • Write investigation records, reports, and communications • Enter required information into appropriate systems on time • Participate in training, team discussions, and improvement activities • Share lessons learned and promote consistent quality practices

🎯 Requirements

• Degree or equivalent and typically requires 4+ years of relevant experience • 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 • 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 ability to work effectively with colleagues in different functions • Working knowledge of 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 • 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

• Yearly bonus opportunity • Competitive compensation package • Equity • Long-term incentive opportunities • Benefits included in McKesson's Total Rewards package

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