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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

McKesson 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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