Sr Associate Quality Specialist, Master Control

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

The Quality Specialist will be required to work within the Quality Management System (QMS) MasterControl to facilitate alignment across and manage multiple assignments simultaneously that support all business activities for McKesson while ensuring compliance to client requirements, proper workflows and appropriate reviews and approvals.

In this position, the incumbent acts as a subject matter expert in all aspects of MasterControl and is required to develop and manage efficient document architecture that is compliant to company Global, Regulatory, Privacy, Ethics and Compliance requirements that support all business activities.

Specific Responsibilities

• Create and/or disable Master Control accounts for those business units supported.
• Reassign tasks to other users in Master Control.
• Activate trainee infocards.
• Creation of configuration documents (and training as required).
• Importation of new documents as required.
• Creation of tracking reports.
• Provide training and/or troubleshooting of the system to users.
• Create and provide appropriate metrics to identify status of quality system tasks (ie. tracking for status, documents approaching expiration, volume of reviews, review time, training completion etc.).
• Provide subject matter expertise during internal audits and external inspections and audits.
• Ensure deployment and implementation process sustainability and effectiveness.
• Keep current updates to applications relevant to Master Control.
• Perform user access reviews per required frequency.
• Support additional system validation efforts brought on by system changes; upgrades and add-ons.

Minimum Qualifications

• Post-secondary education (University degree preferred) in business, operations management, science, engineering or related areas.
• 1+ years of experience and understanding of quality in the pharmaceutical/health care industry.
• Knowledge of cGxPs, regulatory, privacy and compliance requirements are required.

Key Competencies

• Ability to work independently and work well with others and must spend a significant amount of time working with the operations team to understand processes.
• Advance knowledge of risk and compliance methodologies and processes.  This involves strategizing, planning, managing, writing, and/or reviewing the activities and documents.
• Knowledge and competencies in document management software applications and solutions, including experience or training in document management system.
• Strong customer focus and ability to prioritize and adapt to business needs.
• Ability to communicate and work with a very broad spectrum of professional and technical staff to effectively manage documents and records in an efficient and practical manner.
• Experience interacting with regulatory agencies and health authority inspections.
• Excellent organizational, interpersonal and leadership/teamwork abilities.
• Good presentation and problem-solving skills, and ability to make decisions.
• Proven leadership and interpersonal skills.
• Team player.
• Ability to communicate and gain commitment at all levels of the organization.
• Ability to efficiently present key elements of a project in relation to the audience's need.
• Ability to proof-read, edit with strong technical writing skills.
• Strong analytical skills and ability to synthesize.
• Strong collaboration mindset enabling efficient communication between different groups and departments.
• Strong written and oral communication skills.
• Ability to work independently and problem solve.
• Experience with Quality Management Software an asset.

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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