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Management Quality

Location:
Charlotte, NC
Posted:
April 01, 2020

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Resume:

Bernardo E. Ponce

Milltown, NJ ***** // adckuz@r.postjobfree.com // 732-***-****

A proven professional with more than 10 years of System Administration, Quality Systems Management, Project Management, and Supervisory experience. Strong problem solving and decision-making skills with the ability to develop and implement effective action plans. Skilled at understanding the planning cycle, phases, and processes of successful project management. Relationship-building acumen, ability to build consensus, and motivate teams to excellence. Performance driven and self-starter, with an involved style of leadership with the ability to achieve immediate and long-term goals, and meet or exceed desired goals PROFESSIONAL SKILLS

Master Control Software Administrator

Pilgrim Smart Solve Administrator

Knowledge of cGTPs, QSRs, ISO

requirements and other regulatory standards.

Knowledge of 212 CFR Part 11 compliance

Bilingual(Spanish)

PMP aspirant

Knowledge with SQL

Crystal Reports

Risk Management

Training & Development

EDUCATION

BS in Business Administration December 2018

Liberty University Lynchburg, VA

Specialization: Project Management

PROFESSIONAL EXPERIENCE

Quality Management Systems Analyst 04/15-Present

Musculoskeletal Transplant Foundation Edison, NJ

Troubleshoots system and user problems and bring them to the attention of the Department Manager and Management Information Systems (MIS) staff Performs daily tracking of document flow/movement within the system.

Performs System Administration functions including assisting with the development and maintenance of workflows; creating and executing test scripts (or training user personnel to perform this task); maintaining system security through the assignment of roles and rights; maintaining system configurations; keeping abreast of system upgrades and assessing the impact for users.

Acts as the liaison between system users and MIS and vendor representatives

Represents Quality Management on special projects and act as the liaison between Quality Management and team leaders/SMEs to ensure that change management best practices are implemented. Effectively communicate discussion points to Document/Change Management staff.

Assists with creation of Non-Conformances and CAPA’s within Quality Management System.

Develops training program for all EDMS users, including the trainers. Assist in the development of the EQMS training program.

Generates reports, as requested for internal management personnel and external investigators/auditors. Quality Management Specialist 02/06-4/15

Musculoskeletal Transplant Foundation Edison, NJ

Review and coordinate the preparation of controlled documents related to company policies, procedures, and forms for final approval via the use of the Master Control Document System and QAD database.

Performs daily tracking of document flow/movement within the system.

Maintain department organizers and Document Matrices in document control system for areas of responsibility.

Set up user rights, roles, and routes within the document control system.

Issue reports within the document management system as needed.

Providing individual training throughout departments with navigation and use of the Master Control system



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