Job Details

Description:

Position Summary
Describe the purpose of the position in 3-5 sentences. Explain the job role and how it fits within the organization. The description should provide a complete but concise understanding of the position.
Responsible for ensuring compliance and following all regulations and quality systems within our international distribution centers. Perform time and temperature analysis for shipments within the US and LATAM distribution network. Responsible for creating quality events, obtaining dispositions, and product release for products at US distribution centers.
Primary Duties
1. Evaluate shipments using TTOR and MKT principles.
2. Initiating quality events, liaising with manufacturing sites for dispositions and distribution centers for product release.
3. Executes assigned quality projects, with guidance from technical quality expert (depending on level of experience), using engineering principles, business standards, practices, procedures, and project requirements.
4. Assures proper documentation of technical data generated for the assigned projects and/or tasks consistent with applicable quality directives and procedures.
5. Communicate the quality status of materials to internal customers, management, and external suppliers.
6. Develop and implement departmental operational procedures to ensure regulatory compliance (FDA, GMP, ISO, OSHA, etc.).
7. Make recommendations for improving quality & productivity performance.
8. Contribute continuous product and process improvements in areas related to department.
9. Leads the following activities contributing to QMS compliance: CAPA (including analysis of data and trends in complaints, nonconforming materials and root cause analysis), change control, supplier quality, internal audits, quality training, etc.
10. Works with other departments to ensure operational and quality goals are understood and met.
11. Participates and communicates status, business issues, and significant developments in projects.
12. Develop and review procedures (both internal and external).
Supplemental Data
Information that will enhance the understanding of the nature of the job (e.g., number of people directly supervised, total staff supervised, sales volume impacted, operating budget, extent of travel required, etc.)

Makes decisions based primarily on defined guidelines and procedures, but responsible for scheduling of work to meet product demands and deadlines.