Job Summary

Reporting to the 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 A \xe2\x80\x93 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 \xe2\x80\x93 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.

Section C \xe2\x80\x93 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

Career Level \xe2\x80\x93 IC \xe2\x80\x93 Professional \xe2\x80\x93 P3

At McKesson, we care about the well-being of the patients and communities we serve, and that starts with caring for our people. That\xe2\x80\x99s why we have a Total Rewards package that includes comprehensive benefits to support physical, mental, and financial well-being. Our Total Rewards offerings serve the different needs of our diverse employee population and ensure they are the healthiest versions of themselves. For more information regarding benefits at McKesson, please click here.

As part of Total Rewards, we are proud to offer a competitive compensation package at McKesson. 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.

Our Base Pay Range for this position

$68,300 - $113,900

McKesson is an Equal Opportunity employer.

The material contained herein is provided for informational purpose only. All open jobs offered by McKesson on this recruitment system are subject to specific job skill requirements. The job skill requirements, qualifications, and preferred experience are determined by a subsidiary, office or department within the company which is offering the position, and all positions are subject to local prevailing employment laws and restrictions. This would include immigration laws pertaining to work authorization requirements and any other applicable government permissions or compliance.

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McKesson is an equal opportunity employer and values diversity in its workforce. We encourage applications from all qualified individuals and will accommodate applicants\' needs, up to the point of undue hardship, throughout all stages of the recruitment and selection process.

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