Quality Specialist, Master Control - Jobs in Mississauga, ON

Job Description

McKesson is in the business of better health and we touch the lives of patients in virtually every aspect of healthcare. At McKesson Canada, we touch the lives of 12 million Canadians every day. We carry more than 35,000 products in 17 distribution centers and ultimately provide distribution to 6,300 retail pharmacies, 1,350 hospitals, long-term care centers, clinics and institutions all over Canada. But were so much more than a distribution company. Weve automated 2,500 retail pharmacies and dispense over 100 million doses a year through our automation solutions. Manufacturers, healthcare providers and patients count on us for a full range of services that contribute to the quality and safety of care for us all.At McKesson Canada, you’ll help us carry out our mission to improve lives and advance healthcare. Working here is your opportunity to shape an industry that’s vital to us all.Work From Home with fewer fixed days in the office (2300 Meadowvale Blvd, Mississauga)Job SummaryThe Quality Specialist – Master Control, acts as a subject matter expert in all aspects of Master Control.The Quality Specialist works within Master Control to facilitate alignment and mange 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 is required to develop and manage an efficient document architecture that is compliant to company Global, Regulatory, Privacy, Ethics and Compliance requirements that support all business activities. As a Quality Specialist, you will be responsible for the development, revision, and distribution of active master documents such as Policies, Quality Standards, Standard Operating Procedures, Guidance Documents and Work Instructions.The Quality Specialist will be required to work within the QMS to facilitate alignment across multiple documents and may manage multiple assignments simultaneously that support all business activities for McKesson while ensuring compliance to client requirements, proper workflows and appropriate reviews and approvals.Section ASpecific ResponsibilitiesSpecific duties generally include but are not limited to the following:

• Develop and manage a central records management process designed through the lifecycle of document management.
• Control the process for authoring, review, approval and subsequent distribution, archiving and destruction of Master GxP Documents (SOPs, GD’s, WI’s, Master Records, Reports and other GxP documents).
• Develop and maintain site policies/procedures.
• Describe and govern the system to ensure GxP documentation and records are managed in accordance with Global Quality requirements, regulations and GMPs.
• Function as the Subject Matter Expert (SME) on applicable Regulations.
• Provide technical and regulatory guidance with regard to regulations to internal and external stake-holders to ensure overall quality and compliance.
• Create and provide appropriate metrics to identify status of documents (i.e., tracking for status, documents approaching expiration, volume of reviews, review time etc).
• Ensure offsite records storage is aligned and managed within the policies and procedures of the document management system and are integrated with the life cycle approach to the GxP-related documents.
• Create and/or disable Master Control accounts for those business units supported

• 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 of updates to applications relevant to Master Control
• Support additional system validation efforts brought on by system changes; upgrades and add-ons

Section BRequirements and competenciesRequirements:

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

Competencies:

• 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

Career Level P2At McKesson, we care about the well-being of the patients and communities we serve, and that starts with caring for our people. That’s 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$56,600 - $94,300McKesson 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.The materials on this site are provided without warranties of any kind, either expressed or implied, including but not limited to warranties regarding the completeness of information contained on this site or in any referenced links. While McKesson attempts to update this site on a timely basis, the information is effective only as of the time and date of posting.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.The information on this site is for information purpose only and is not intended to be relied upon with legal consequence.Current employees must apply through internal career site.Join us at McKesson!Quick Apply

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