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This position provides Quality Assurance (QA) oversight to Suppliers, Service Providers and Contract Labs to ensure compliance with applicable regulatory requirements and Standard Operating Procedures (SOPs). Serves as the quality liaison to suppliers and executes and manages on-going qualification for Suppliers, Service Providers, and Contract Labs.
Primary Duties and Responsibilities for the Supplier Quality Management Specialist include the following:
- Manages or supports the supplier management program. Suggests, develops and/or implements improvements to the program to ensure it maintains compliance with current regulatory and industry expectations.
- Performs on-site audits to ensure compliance to regulatory standards and internal procedures. Completes audit reports and ensures appropriate CAPAs are identified by the supplier when necessary. Site audits require up to 25% travel, both domestic and international.
- Performs desktop audits to ensure compliance to regulatory standards.
- Owns the Material Review Board process. Schedules and facilitates meetings ensuring cross-functional input and decision making on supplier-related topics, including real-time monitoring of supplier performance and documentation of supplier scorecards.
- Manages Supplier Complaints to ensure the investigation into issues are completed and appropriate CAPAs are identified and implemented by the supplier.
- Manages the Raw Material Change Evaluation process.
- Manages and maintains Quality Agreements with suppliers.
- Provides input into investigations involving Supplier/Service Provider/Contract Lab deviations.
- Responsible for writing, reviewing and/or approving documentation and procedures related to the supplier management program.
- Provides support on various other quality assurance issues as necessary.
- May disposition raw materials, including rejection of materials in collaboration with the Manufacturing QA team.
- Assists with client and regulatory audits as requested by management.
- Assists in conducting internal audits as requested by management.