Analytical Method Validation Specialist
Mallinckrodt Pharmaceuticals | |
United States, Missouri, St. Louis | |
Aug 28, 2024 | |
Job Title Analytical Method Validation SpecialistRequisition JR000014442 Analytical Method Validation Specialist (Open)Location St. Louis, MOAdditional Locations Job Description Summary The analytical method validation review specialist is responsible for conducing comprehensive reviews of analytical methods to ensure compliance with regulatory standards and are suitable for intended use. This role is critical in maintaining product quality and minimizing risk associated with analytical processes. The scope of responsibility also includes review/improvement/implementation of analytical methods of the St. Louis Plant laboratory systems.Job Description ESSENTIAL FUNCTIONS:
DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS:
MINIMUM REQUIREMENTS: Education: BS in Chemistry, Chemical Engineering, related science or equivalent combination of education, experience, and competencies. Experience: Minimum of 5 years' of pharmaceutical experience required with prior experience in analytical method validation and quality assurance experience. Strong understanding of analytical chemistry principles and techniques. Knowledge of pharmaceutical regulations including current GxP, GAMP5, Part 11 and Data Integrity requirements. Knowledge of ICH Q7 and Q11 is required. Preferred Skills/Qualifications:
COMPETENCIES: Comfort Around Higher Management, Organizational Agility, Customer Focus, Drive for Results, Presentation Skills, Managing through Systems, Written Communication, Decision Quality ORGANIZATIONAL RELATIONSHIP/SCOPE: Reports to the Principal Compliance Chemist. Must be self-directed to manage strategic/compliance projects and complaint investigations. Operates independently under limited supervision. Leads technical, cross-functional teams. Plans, schedules, and arranges own and other's activities in accomplishing objectives. Contacts involve matters of high importance to the organization and includes Customers, Commercial, Manufacturing, Quality, HSE, Engineering, and R&D. WORKING CONDITIONS:
DISCLAIMER: The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of employees assigned to this position. |