Hybrid Senior Specialist, Clinical Supply Quality Assurance

at MSD

• Job title: Senior Specialist, Clinical Supply Quality Assurance
• Job type: Full Time
• Experience level: Senior
• Salary: $104,200 - $163,900 per year
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, West Point, United States

About the role

• Quality Assurance Specialist ensuring compliance with regulations and quality in clinical supply chain for pharmaceutical company. Responsible for oversight of clinical supply materials and processes.

Responsibilities

• safeguard the rights and well-being of patients; the welfare of animals; comply with applicable global regulatory requirements through sound processes and procedures
• provide independent assurance that delivers high quality data and clinical supplies
• Evaluation and disposition of clinical supply materials with the assurance that the materials were produced in conformance to all applicable policies/procedures of our Company and compliance with all governing regulations
• Coordinate and/or support the preparation of procedures, processes and quality improvements
• Assists in the coordination of significant quality events including fact finding, investigation, coordination of clinical quarantine and recovery actions
• Collaboration across cross-functional and business areas to ensure robust processing, continuous improvement and cross-functional team building
• Providing on-the-floor coaching/guidance of operational and technical issues; providing immediate resolution on the shop floor to deviations and potential deviations
• Completing projects to improve the performance of our processes, including continuous process improvements, investigation Corrective/Preventative Actions (CAPAs), and value capture projects that seek to improve outcomes, reduce cost, or lower our processing cycle times
• Managing investigation, change request and project timelines to ensure key compliance and customer due dates are met; escalating any potential misses and develop remediation plans when possible
• Actively using and championing the use of Lean Six Sigma (LSS) and our Company's Production System (PS) tools, both in problem-solving and day-to-day operational activities

Requirements

• Bachelor's degree with a concentration in a scientific-related discipline
• Minimum of 5 year's experience in the pharmaceutical or equivalent industry Good Manufacturing Practice (GMP) related field
• Familiarity with batch disposition (release) activities
• Prior experience reviewing and approving investigations, deviation management support, and Corrective/Preventative Actions (CAPAs)
• Background in quality control, quality assurance, auditing or regulatory affairs
• In-depth working knowledge of cGMPs and of regulatory requirements as they apply to the pharmaceutical field or a related area
• Basic understanding of the use and maintenance for Microsoft applications (such as Excel, Outlook, Access)

Benefits

• medical
• dental
• vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days