Quality Site Specialist

at  McKesson

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.

JOB SUMMARY

Reporting to the Senior Manager, Quality, Pharmaceutical Distribution, the Quality Site Specialist (QSS), will be responsible for ensuring a product or service meets the established standards of quality including reliability, usability and performance.

At this level, the Quality Site Specialist typically:

• Works under limited direction with work being evaluated upon completion to ensure objectives are met
• Determines and develops approach to solutions.
• Frequent interorganizational and outside customer contacts.
• Represents the department on projects and may perform in project leadership role.
• Represent the department and is the main quality point of contact at the DC level.
• Provides resolutions to a diverse range of complex problems using judgement within defined policies and practices.

SECTION C – KEY REQUIREMENTS

Education and Experience:

• B.SC. in Chemistry, Biology or equivalent experience.
• Quality inspection, auditing and testing experience
• Experience in execution of equipment qualification or mapping
• Experience with implementation of corrective action programs
• Product or industry-specific experience
• Strong computer skills including Microsoft Office, QA applications and databases
• Knowledge of tools, concepts and methodologies of QA
• Knowledge of relevant regulatory requirements
• 4+ years of relevant experience

Knowledge and Skills:

• Demonstrate strong leadership in a professional environment
• Ability to manage time and prioritize tasks is an essential characteristic
• Communication skills - verbal and written
• Data collection, management and analysis
• Problem analysis and problem solving
• Planning and organizing
• Judgment
• Decision-making
• Customer service orientation
• Ability to motivate in a teamwork environment
• Capacity to work under limited direction

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. 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.

SECTION A – SPECIFIC RESPONSIBILITIES

Certain responsibilities that are typically associated with a job as Quality Specialist are included in Section B. Specific duties generally include but are not limited to the following:

• Execute equipment qualification and mapping
• Execute qualification protocols
• Manage the temperature monitoring system
• Draft quality assurance policies and procedures
• Interpret and implement quality assurance standards
• Evaluate adequacy of quality assurance standards
• Review the implementation and efficiency of quality and inspection systems
• Plan, conduct and monitor testing and inspection of materials and products to ensure finished product quality
• Document internal audits and other quality assurance activities
• Investigate customer complaints and non-conformance issues
• Collect and compile statistical quality data
• Analyze data to identify areas for improvement in the quality system
• Develop, recommend and monitor corrective and preventive actions
• Prepare reports to communicate outcomes of quality activities
• Coordinate and support on-site audits conducted by external providers
• Evaluate audit findings and implement appropriate corrective actions
• Monitor risk management activities
• Responsible for document management systems
• Assure ongoing compliance with quality and industry regulatory requirements.

SECTION B – GENERAL RESPONSIBILITIES

• Promotes understanding of quality standards and processes with Distribution Directors in the DC.
• Identify training needs and organize training interventions to meet quality standards
• Ensures proper preparation, execution and follow-up of Regulatory Inspections by maintaining the inspection file, managing audit documents and response actions.