Quality Site Specialist
Milton, Canada Job ID JR0126307 Category Regulatory Affairs, Business & Strategy Post Date Feb. 24, 2025McKesson 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 Sr. 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 – 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.
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.
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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. The pay range shown below is aligned with McKesson's pay philosophy, and pay will always be compliant with any applicable regulations. 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.
Our Base Pay Range for this position
$71,400 - $119,000McKesson is an Equal Opportunity Employer
McKesson provides equal employment opportunities to applicants and employees and is committed to a diverse and inclusive environment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, age or genetic information. For additional information on McKesson’s full Equal Employment Opportunity policies, visit our Equal Employment Opportunity page.
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Benefits
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Hiring Process
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