Senior Regulatory Compliance Analyst (Technician) (Ciudad Juárez)

Job Function

Quality

Job Sub Function

Quality Control

Job Category

Business Enablement/Support

All Job Posting Locations

Ciudad Juarez, Chihuahua, Mexico

Job Title

Senior Regulatory Compliance Analyst – Plant Salvarzar, Ciudad Juarez

Purpose

Under supervision supports monitoring of Compliance Metrics and dashboard maintenance for different forums. Also, supports Site Internal Audit Program and External Audit Readiness activities as required.

You will be responsible for

• Supports monitoring of Compliance Metrics and dashboard maintenance to be presented in different forums.
• Supports the Site Audit Readiness Program, as required.
• Support Compliance training education programs applicable to the organization.
• Ensure compliance with the Quality Policy in all activities.
• Interacts with all Departments and provides support to company activities as required.
• Provides periodic reports, completes special assignments, as assigned.
• Creates procedure/document changes and performs implementation tasks as applicable.
• Supports and promotes the safety and industrial hygiene objectives of the plant.
• Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies, and procedures.
• Performs a variety of other duties of a complexity commensurate with the job level as assigned or required.
• Follows compliance regulations and standards applicable to the organization.
• Knowledge of operating procedures and related computer systems required.
• Communicates business-related issues or opportunities to the next management level.
• Follows all company guidelines related to health, safety and environmental practices as applicable.
• For supervisors or managers: ensures subordinates follow all company guidelines related to health, safety and environmental practices.
• Provides support on assignments such as developing executive-level presentations for different forums with high visual content based on Quality Systems data.
• Analyzes data and trends.
• Provides general consultancy on the access and use of audit module system.
• Executes periodic reports and maintains the required databases to track progress on action plans and effectiveness monitoring plans raised from audit observations.
• Supports readiness activities for external audits, as required.
• Participates in site internal audit program.

Qualifications / Requirements

• High school or technical career. Preferably graduated from an engineering degree.
• Experience 2 to 4 years; if bachelor degree completed, no experience required.
• Experience working in an FDA-regulated environment (desirable).
• Good written and oral communication skills, including report writing, presentation and training skills, in both English and Spanish.
• Computer literate in Microsoft Office or similar.
• Accomplishes objectives in a timely manner with limited day-to-day supervision.
• Good interpersonal skills; customer service oriented.
• Working knowledge of Current Good Manufacturing Practices, data integrity, and all applicable standards, regulations and requirements for the organization (preferred).
• Experience as a quality systems auditor (preferred).