Open To Work
Aida Cruz-Santoni
Becton Dickinson (CR Bard Shannon LTD)
Guaynabo
Work Preference
Job Search Status:
Open to work
Desired start date:
Immediately
Desired Job Title
Sr. Quality Systems LeadTraining SupervisorDocument Control Supervisor
Location Preference
HybridRemoteOn-Site
Location:
Guaynabo, Puerto RicoSan JuanCaguasGurabo
Open to relocation:
No
Important To Me
Work-life balanceCareer advancementCompany CultureFlexible work hoursHealthcare benefitsWork from home optionPaid time off401k matchPaid sick leavePersonal development programsStock Options / Equity / Profit SharingTeam Building / Company Retreats4-day work week
1
Certification
17
years of professional experience
Talented Manager with expert team leadership, planning and organizational skills built during successful career. Smoothly equip employees to independently handle daily functions and meet customer needs. Diligent trainer and mentor with exceptional management abilities and results-driven approach. Detail-oriented team player with strong organizational skills. Ability to handle multiple projects simultaneously with a high degree of accuracy. Strong leader and problem-solver dedicated to streamlining operations to decrease costs and promote organizational efficiency. Uses independent decision-making skills and sound judgment to positively impact company success.
Work History
Sr. Quality Systems Lead
7 Years 7 Months- Manage the quality systems for multiple areas, including laboratories, manufacturing, and assembly, for two business lines in a 700-personnel site.
- Oversee and coordinate inspections, investigations, complaints review system, batch records, manufacturing documentation, risk mitigation activities, GMPs training programs, and CAPAs.
- Participate in management reviews and meetings.
- Establish and enforce SOPs and metrics.
- Appointed as the principal internal auditor.
- Lead a team of three people.
- Assumed the role after an audit finding that required a remediation plan.
- Steered the analysis, testing, and migration directing 20+ people, leading to favorable results for the second inspection.
- Led the implementation of a scanning system with substantial improvements in document management.
- Leverage technology resources to speed up activities and streamline report systems.
- Steer multiple initiatives to speed the release of raw materials, in-process materials, bulk materials, and finished products, as well as process improvement of batch records and turnaround times.
- Selected as the company representative during regulatory inspections, including interacting with inspectors/auditors, acquiring required information, and assisting with corrective action and/or remediation plans.
- Involved in FDA, European, and foreign countries' regulatory agencies’ inspections.
- Developed and prepared the Annual Quality Product Review and recommended actions based on statistical trends of release parameters.
- Lead the lot release, record retention, and change control activities to ensure that changes are implemented in a controlled manner and do not compromise product safety, efficacy, or quality.
Training Supervisor
2 Years 5 Months- Assessed new employee skills and strengths to provide customized training.
- Collaborated with company leaders and department managers to determine training needs.
- Evaluated success of training programs and recommended improvements to upper management to enhance effectiveness.
- Updated employees with latest policies, procedures and compliance standards.
- Integrated technology resources into courses to diversify instruction.
- Monitored training reports within learning management system for respective roles to promote initial and annual training completion.
- Created and maintained detailed training records and reports for management review.
- Selected or wrote appropriate curriculum for specific course topics.
- Provided recommendations for process improvements and discontinuation of ineffective or outdated methods.
- Planned and conducted staff trainings with emphasis on [Type] areas.
- Verified training program compliance with applicable laws and regulations.
- Compiled training handbook and related course materials.
- Produced training manuals, presentations and resources for enhanced learning.
- Coordinated with department leaders to identify training needs and develop targeted solutions.
- Developed and executed strategies to improve training program performance.
- Conducted orientation sessions and organized on-the-job training for new hires.
- Trained staff during demonstrations, meetings, conferences, and workshops.
- Facilitated high-quality training program delivery to employees and external stakeholders.
- Selected, developed and delivered classroom and online training materials to meet program needs.
- Communicated all learning and performance objectives, schedules, and training assessments to upper management.
- Reviewed and edited all training materials for accuracy and company policy compliance.
- Scheduled and coordinated training sessions, including booking facilities and arranging catering.
- Worked with central management to identify, plan, align, and address training needs.
- Trained new hires to perform cross-training exercises with experienced workers.
- Organized and edited training manuals, multimedia visual aids, and other educational materials.
- Streamlined HR efficiencies, coordinated new hire orientations and provided onboarding and training for new employees.
- Managed new employee orientation training process for more than [Number] employees each year.
- Selected and assigned instructors to conduct specific training programs.
- Coordinated and prioritized required training courses for [Type] employees.
- Conducted training courses and prepared videos for long-term use.
- Developed departmental systems and procedures to better align workflow processes.
- Tested all training software and hardware prior to commencing training programs.
Document Control Supervisor
9 Years 9 Months- Managed all aspects of the daily operations of the Document Management Center, including change control and record retention.
- Ensured revision, filing, distribution, and change control according to regulations and policies (Procedures, Specifications, Forms, and Batch Records).
- Supervised 10+ employees.
- Evaluated current document processes, suggested methods for change and implemented successful improvements.
- Enforced use of standardized forms and templates to achieve uniformity of communications across departments and functions.
- Carefully reviewed all documents and reports for completeness and accuracy.
- Created project control documentation to support needs of important projects.
- Collaborated across departments and levels of management to gain consensus on procedural documentation.
- Established, improved and reinforced document management systems to handle current and expected requirements.
- Created and maintained user accounts and properly routed documents for approval and training.
- Managed training courses, setup and maintenance for document control systems.
- Monitored due dates and deadlines and worked to submit all documents on time or early.
- Checked accuracy and completeness of documents to identify deficiencies and recommend corrective actions.
- Scanned, filed and transmitted various documents and adhered to digital filing procedures.
- Supported end-user access requirements by establishing compliant systems and effective access policies.
- Oversaw creation, routing and data input of bills of materials, ECOs, ECRs and ISO documents.
- Assessed impact of emerging technology and system upgrades on workflow.
- Uploaded company procedures and policies to EDMS, routing for approval and training.
- Utilized [Software] to scan and clean up project documents.
- Promoted efficient document processing by maintaining orderly and clean control room.
- Maintained legally compliant, highly secure and user-friendly content to facilitate smooth use by internal and external stakeholders.
- Assisted with document troubleshooting and recovery of corrupt documents and files.
- Contributed to design and implementation of overall corporate documentation standards, numbering conventions and templates.
- Managed regulatory requirements and audit support needs by completing and submitting accurate paperwork.
- Identified areas of weakness and recommended or implemented process improvements.
- Completed transmittal logs and stored in files for specified durations.
- Worked with internal team members to remedy issues with preemptive solutions.
- Managed file archival and information retrievals.
- Performed document reproduction, printing documents from electronic sources such as email attachments, PDF files and cloud storage.
- Prepared documents for projects in accordance with project manager, team, or client specifications.
- Converted documents from one application to another.
- Maintained organized and efficient document flows by using excellent planning and multitasking skills.
- Worked with internal staff to process documents and sent for closing.
Education
Bachelor of Science - Biology
Master of Science - Clinical Psychology
Ph.D. - Psychology Counseling
Skills
Regulatory Compliance
Project Management
Validation Protocols
Internal Audits
Remediation Plans
NC Investigation
CAPAs
Risk Management
Supplier Qualification
Training
Data Analysis
Certification
- Certified Quality Auditor, ASQ
Additional Information
Technology: MS Office Suite, Microsoft Teams, TrackWise, Livelink, Qumas, WindChill, Documentum, DocuWare, PDM, JD Edwards, and MFG-Pro .
Languages
Spanish
Native language
English
C2
Proficient
Timeline
Sr. Quality Systems Lead
Becton Dickinson (CR Bard Shannon LTD)
12.2018 - CurrentRead More
Training Supervisor
Becton Dickinson (CR Bard Shannon LTD)
12.2018 - 05.2021Read More
Document Control Supervisor
Becton Dickinson (CR Bard Shannon LTD)
03.2009 - 12.2018Read More
Ana G. Méndez
Ph.D. from Psychology Counseling
Read More
Carlos Albizu University
Master of Science from Clinical Psychology
Read More
University of Puerto Rico
Bachelor of Science from Biology
Read More