Sr. Quality Site Specialist

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 Reporting to the Sr. Manager Quality, Pharmaceutical Distribution, the Senior Quality Site Specialist (SQSS), will be responsible for ensuring product or service meets the established standards of quality including reliability, usability and performance. The incumbent will support the pharma distribution businesses at a Distribution Center level in various quality assurance activities. At this level, the Senior Quality Site Specialist typically: Acts as a key contributor in a more complex/critical environment. Acts as a resource for colleagues with less experience; may direct the work of others without formal management responsibilities; may utilize internal or external resources to accomplish goals Develops resolutions to complex problems that require the frequent use of creativity. Uses judgement within broadly defined policies and practices. Anticipates change and directs or redirects efforts. Accomplishes work without considerable direction and exerts significant latitude in determining objectives of assignment. Anticipates change and communicates with management pre-identified potential solutions Interacts with senior management and senior customer personnel on matters requiring coordination across organizational lines. Represents the department on projects and may perform in a project leadership role . Section A - Specific Responsibilities Certain responsibilities that are typically associated with a job as Senior Quality Site 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 Assume leadership role among DC QSSs (such as but not limited to task delegation, ensure timely completion of the team's quality activities). Section B - General Responsibilities Promotes understanding of quality standards and processes with the national distribution network. Identify training needs at a national and interdepartmental level and organize training interventions to meet quality standards Support DCs in the 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 or in a related field. Knowledge of Canadian drug GMP environment and other applicable regulations pertaining to DIN products, narcotics and precursors. Experience in Quality investigations, inspection, auditing and testing Experience with implementation qualification and validation program Experience in validation, qualifying and temperature monitoring program Strong computer skills including Microsoft Office, QA applications and databases Knowledge of tools, concepts and methodologies of QA  Knowledge of cold chain shipping requirements. Knowledge of regulations and guidelines for temperature control of drug products during storage and transportation. 5 years of work experience in pharmaceutical industry in Quality Assurance 3 years Experience with equipment qualification/computer system validation (CSV) across GXP landscape. Knowledge and Skills: Demonstrate strong leadership in a professional environment Ability to motivate in a teamwork environment Ex