Supplier Quality Contractor - Fort Washington, United States - Katalyst Healthcares and Life Sciences

Description

• Supplier and/or Material Lifecycle Management, including:
• Subject Matter Expert (SME) in the selection, onboarding, monitoring, and disengagement of new and existing suppliers or materials. Activities may include Quality Agreements, Audit Remediation, Data/Metrics collection, Change Control and Specification review/approval, Approved Supplier List maintenance, and others as required by procedure.
• Leads the development and introduction of new process and procedures which may impact multiple functions or regions. Brings forward innovative process improvements to drive compliance and/or efficiency.
• Design and implement quality and compliance improvement programs and initiatives. Innovate solutions to significant quality systems gaps and lead continuous improvement projects
• Independently manage and prioritize a highly complex and diverse workload, ensuring that deliverables are on-time, accurate, and meet their intended objective.
• Independent decision-making authority and accountability for material disposition and compliance decisions with significant impact to customer service.
• Engagement and support of cross-functional projects, such as material selection/onboarding initiatives, Sourcing selection/new supplier qualification projects, material governance, CAPAs, quality system improvement projects, and other initiatives
• Provide detailed and/or summary communications to QA and cross-functional management on status of key initiatives and issues.

• Bachelor's Degree is required; a degree in a technical field (Engineering, Sciences, or similar
• minimum of 6 years of experience in a technical function (Quality Assurance, Engineering, R&D, Data Analyst) or Supply Chain function (Planning, Sourcing, Operations); experience working in a Pharmaceutical, Medica Device, or Consumer Health industry is preferred.
• Experience with inspections or audits and developing actions plans to address deficiencies identified is preferred
• Familiarity with root cause analysis, six sigma tools, or related methodologies is highly preferred Knowledge, Skills, and Abilities:
• bility to successfully utilize Data Management tools and software to manipulate data is required (for example, Excel, Minitab, SAP, Etq, or related software)
• Detailed working knowledge of cGMP requirements and current FDA enforcement issues is highly preferred.
• Demonstrated ability to collaborate as a team member or team lead with internal/external partners to enhance relationships and interactions, including interfacing with management to inform, drive change, and provide direct feedback.
• Independently prioritize a highly complex and diverse workload, ensuring timelines and objectives are met.
• bility to value diverse perspectives and use that diversity to achieve results is required.
• high attention to detail
• Fluency in English