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Clinical Supplies Quality Assurance Specialist
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We are seeking a highly skilled Clinical Supplies Quality Assurance Specialist to join our team at Merck Sharp & Dohme (MSD). As a key member of our Quality Assurance group, you will play a critical role in ensuring the quality and compliance of our clinical supplies.
Key Responsibilities- Evaluate and disposition of clinical supply materials to ensure they meet our high standards of quality and regulatory requirements.
- Coordinate and support the preparation of procedures, processes, and quality improvements to enhance our clinical supply chain.
- Assist in the coordination of significant quality events, including fact-finding, investigation, and recovery actions.
- Collaborate with cross-functional teams to ensure robust processing, continuous improvement, and cross-functional team building.
- Provide on-the-floor support for operational and technical issues, and provide immediate responses to deviations and potential deviations.
- Complete projects to improve the performance of our processes, including continuous process improvements, investigation Corrective/Preventative Actions (CAPAs), and value capture projects.
- Manage investigation, change request, and project timelines to ensure key compliance and customer due dates are met.
- Bachelor's degree in a relevant scientific or engineering field.
- Minimum of two years' experience in the pharmaceutical or equivalent industry, including Technical, Engineering, Quality, or Operations.
- Effectiveness and creativity in approaching and solving technical problems.
- In-depth working knowledge of current Good Manufacturing Practices and regulatory requirements.
- Basic understanding of Microsoft applications, including Excel, Outlook, PowerPoint, Teams, and/or Access.
- Evidence of leadership skills, highly developed oral and written communication skills, and stakeholder management and conflict resolution skills.
- Demonstrated teamwork skills and ability to work independently.
- Attention to detail, flexibility, and awareness of production and quality control problems.
- Familiarity with batch disposition (release) activities and prior batch disposition experience.
- Prior experience reviewing and approving investigations, deviation management, and Corrective and Preventative Actions (CAPAs).
- Background in quality control, quality assurance, auditing, or regulatory affairs.
- Ability to independently manage multiple priorities and projects.
- Ability to lead and support teams of a cross-functional and multi-level nature.
- Demonstrated analytical and problem-solving skills, knowledge of Lean Six Sigma, and Project Management.
- Computer skills, including Enterprise Resource Planning and Deviation Management (SAP), VeevaVault, and TrackWise.
Merck Sharp & Dohme (MSD) is a research-driven biopharmaceutical company with a rich history of innovation. Our mission is built on the simple premise that if we 'follow the science,' great medicines can make a significant impact on our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.
Our company has a presence in Switzerland since 1963, with a regional office and manufacturing/packaging facility in Lucerne. We are proud to be certified as a 'Top Employer Switzerland' and 'Top Employer Europe,' demonstrating our commitment to our employees and the community around us.
We are a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
