Unclassified - Cincinnati, OH
posted 5 months ago
The Vendor Quality Control Analyst is a critical role within Baxters North America Inc, responsible for ensuring that vendor operations, products, and services comply with both government regulations and company quality standards. This position involves conducting thorough audits and testing of products, materials, and processes to assess their effectiveness and adherence to company expectations. The Analyst will analyze and monitor various metrics and key performance indicators (KPIs) to propose improvement initiatives that enhance vendor performance and product quality. Additionally, the role requires collaboration with vendors to identify alternative sources that can mitigate risks and resolve any issues that arise. The Analyst will also assist in drafting and negotiating service-level agreements (SLAs) to ensure that performance metrics, responsibilities, expectations, and penalties are clearly defined and understood. In this role, the Vendor Quality Control Analyst will ensure compliance with the 21 CFR 117 Part G Supplier Control Program by evaluating supplier controls and monitoring food safety risks. The Analyst will make informed recommendations regarding supplier controls and approval statuses, working closely with suppliers and the BNA procurement team to address any identified weaknesses. The position also involves developing and documenting BNA expectations in collaboration with product development and procurement teams to maintain consistent compliance with established standards. The Analyst will publish supplier documentation to TraceGains and manage supplier connections, review supplier questionnaires, and conduct risk assessments of supplier controls using FDA Preventive Controls guidelines. The Analyst will be responsible for conducting supplier performance evaluations and establishing response plans to drive improvements as necessary. Regular updates will be provided to BNA Leadership, and the Analyst will interact with BNA customers to communicate expectations regarding supplier controls and performance. The role also includes establishing and maintaining a supplier performance evaluation tool, acting on results and trends to ensure the quality and safety of products. In the absence of the Vendor Quality Control Specialist, the Analyst will ensure that their responsibilities are fulfilled and will perform other duties as assigned.