Quality Specialist (20 month contract)

Benefits

Additional Information

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 This position is responsible for implementing Corporate and McKesson Specialty Health (MSH) quality management system activities and compliance with business processes based on established procedures, relevant regulations and industry guidelines. The Quality Specialist is responsible for effective understanding of cross-functional process and to conduct thorough analysis of quality initiatives and their impact on the overall MSH business prior to implementation. In addition, this position is responsible for communicating with Quality Management and key business stakeholders with regards to any audits, trends, or matters that affect the MSH business unit. The position will also work closely with other Quality Specialists to ensure compliance with corporate, client, and regulatory requirements. Section A: Specific Responsibilities Take responsibility for overseeing, planning, and performing business process compliance activities Identify compliance risks and bring to the attention of management. Design, recommend, and implement changes to processes and systems. Regularly monitors and evaluates activities to identify potential risks and non-compliances. Control the process for authoring, reviewing, approval and subsequent distribution, archiving and destruction of controlled documents (SOPs, GD's, Wl's, Reports and other GxP documents) Describe and govern the system to ensure GxP documentation and records are managed in accordance with Corporate Quality requirements, regulations and client requirements. Support with external audits and post audit activities. Conducts root cause analysis and evaluation of CAPAs for non-conformances to procedures. Conducts analysis and prepares metric reports on compliance with quality management systems (i.e., tracking document status, documents approaching expiration, volume of reviews, review time, training completion, etc), as well as status of deviations and CAPA. Escalate overdue tasks as needed. Coordinate, plan and execute scheduled self-inspections in accordance with applicable Standard Operating Procedure(s) and work instructions, as assigned by Quality Management Issue internal audit reports and follow up on CAPA/commitments. Ensure records storage for Quality Department documentation 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 Review applicable Change Control documents to ensure referenced changes are identified and are compliant Section B: General Responsibilities Function as the Subject Matter Expert (SME) on applicable Regulations Provide technical and regulatory guidance with regard to regulations and external stakeholders to ensure overall quality and compliance Makes continuous recommendations for procedural improvements and problem solve to improve procedures by providing recommendations Keep current updates to applicable Regulations Section C: Competencies Post-secondary education (University degree preferred) in business, operations management, science, engineering or related areas preferred Four to six years' experience and understanding of quality in the pharmaceutical/health care industry Thorough knowledge of cGxPs, regulatory, and compliance requirements are required Ability to work independently and work well with others; must spend a significant amount of time working with the operations team to understand processes. Advanced 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 broad spectrum of professional and technical staff to effectively manage documents and records in an efficient and practical manner Excellent organizational, interpersonal and leadership/teamwork abilities. Good presentation and problem-solving skills, and ability to make decisions. Proven leadership and interpersonal skills. Ability to communicate and gain commitment at all levels of the organization. Ability to efficiently present key ele

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