Angel Hurtado
Ogden,UT
Summary
Objective:
To apply extensive regulatory experience in the medical device and food industries, as well as expertise as a MasterControl system administrator, to deliver outstanding technical support to clients and ensure optimal configuration, administration, and maintenance of the MasterControl system
Summary:
I am a skilled MasterControl system administrator with over 5 years of experience in document management and 30+ years of regulatory experience in the medical device and food industries. I have a strong track record of ensuring compliance with relevant regulations and standards. Areas of expertise include technical support, system configuration, and administration.
Overview
25
25
years of professional experience
Work History
Compliance Manager
Vobev
07.2022 - Current
- Manage Quality Assurance team, responsible for ensuring compliance with regulatory requirements and industry standards.
- Developed and implemented quality procedures, ensuring compliance with regulatory requirements and industry standards.
- Conducted internal and external audits to identify and address quality issues, implementing corrective actions as necessary.
- Worked collaboratively with cross-functional teams to identify and implement process improvements to increase efficiency and reduce errors.
- Manage risk management process, identifying and mitigating potential quality risks.
- Provided training and coaching to new employees on quality systems and procedures.
- Monitored and reported quality metrics, identifying areas for improvement and implementing corrective actions.
- Manage, implement, and create Master Manufacturing templates for Co-Manufacturing.
- Designed, established, and implemented a release-for-sale process, ensuring timely and efficient delivery of quality products to customers.
- Audited food safety practices to evaluate performance and deliver effectiveness of preventive controls.
- Developed and delivered training programs to inform new and current employees about compliance issues
Document Control Manager
Vobev
07.2020 - 07.2022
- The main point of contact for MasterControl technical support.
- Ensured effective configuration, administration, and maintenance of six different modules within our QMS.
- Test, document, and perform validation for system changes each quarter.
- Perform timely investigations of issues within the system and recommended, implemented, and document solutions.
- Worked with MasterControl, implementation specialist, and technical account managers to resolve issues; tracked and trended issues and communicated with impacted stakeholders
- Assisted business process owners with technical issues related to module implementation and/or existing module configuration; supported projects and initiatives from start through completion
- Managed user roles and access rights in the system
- Developed and executed the companies strategy for building and maintaining Infocards, courses, workflows, vaults, lifecycles, processes, e-forms, Mx Records, Supplier
- Developed and maintained configuration and maintenance procedures for QMS.
- Proactively analyzed regulatory, business, and customer requirements, proposed and implemented required improvements to MasterControl while maintaining compliance with internal processes
- Consulted, collaborated, and partnered with cross-functional stakeholders, subject matter experts, and business process owners on data for process enhancements
- Performed ongoing evaluation of internal controls, analysis, and maintenance of documentation as it relates to supporting system improvements
- Built reports and analytics for users
- Generated trending data to support system effectiveness
- The main participant in cGMP compliance audits by customers, SQF, USDA, NSF Sport, and/or other regulatory bodies
- Promote a safe positive, and inclusive work environment
- Developed and executed system implementation plans to permit integration of users and documentation for company mergers
Document Control Supervisor
Merical
10.2018 - 07.2020
- Supervised and managed a team of 5 document control specialists in the management and maintenance of the document control system.
- Carefully reviewed documents and reports for completeness and accuracy.
- Scanned, filed, and transmitted various documents and adhered to digital filing procedures.
- Checked the accuracy and completeness of documents to identify deficiencies and recommend corrective actions.
- Monitored due dates and deadlines and worked to submit all documents on time or early.
- Conducted regular audit checks to ensure adherence to quality standards, identifying and resolving any issues that arose.
- Provided training and coaching to new employees on document control processes and procedures.
- Managed document control database, ensuring accuracy and completeness of records.
- Responsible for document scanning, indexing, and retrieval processes.
- Revised and implement new customer onboarding
- Managed supplier verification program
- Managed calibrations and work order documentation
Accounts Payable Specialist
Regency Excavation
10.2016 - 10.2018
- Assisted manager in formulating year-end financial reports to determine the financial performance of companies.
- Documented petty cash transactions in a petty cash journal to summarize payments rendered, maintaining accurate records.
- Handled trade payable documentation by reviewing month-end accruals.
- Reconciled bank accounts to verify the accuracy of cash records.
- Streamlined productivity by decreasing time-wasting tasks and helping supervisors.
- Oversaw bookkeeping and accounting systems and entered data into systems accurately.
- Developed client rapport by efficiently addressing incoming correspondence and resolving 30-50 A/P inquiries per day.
- Studied past records to detect duplicate statements and fraud, avoiding penalties for non-compliance.
- Contributed to producing and interpreting improved finance-related methods to establish consistency with accounts payable prerequisites.
- Investigated daily variances and corrected errors to resolve discrepancies.
- Reviewed vendor invoices for appropriate documentation and validity prior to payment.
- Assisted in analyzing company finances to develop effective cost reduction and revenue maximization strategies.
- Managed invoices for new materials and parts.
- Prepared month-end closing entries for detailed reporting and recordkeeping.
- Maintained good working relationships with vendors and resolved disputes.
- Updated accounting ledgers and journals to balance statements and maintain consistent records.
- Stored office and client records on secured servers to prevent data losses, conducting regular backups.
- Prepared vendor invoices and processed incoming payments.
- Created new processes for on-time accounts payable procedures.
Production Supervisor II
Fresenius Medical Care
03.2013 - 02.2015
- Evaluated team member performance regularly to identify and resolve productivity concerns.
- Established clear priorities and production quality standards.
- Trained staff of direct labor employees to perform assembly and manufacture of specified products.
- Implemented program changes to identify and quickly resolve root cause issues bottlenecking production levels.
- I successfully managed a group of 70+ employees, prioritizing the timely resolution of issues to ensure that productivity goals were consistently met. Through effective communication and problem-solving skills, I was able to foster a collaborative and positive work environment while delivering quality results.
- Developed and implemented Standard Operating Procedures (SOPs), policies, and procedures to ensure efficient and effective operations within the organization. This involved working collaboratively with cross-functional teams, conducting thorough research and analysis, and communicating effectively with stakeholders at all levels of the organization.
- Performed audits
- I had the opportunity to meet with the FDA during audits and actively participated in reviewing and improving our processes. This experience provided me with valuable insights into regulatory compliance and quality assurance
Lead Senior Technical Specialist
Fresenius Medical Care
03.1998 - 02.2013
- Oversaw the production and quality of production on shift.
- Ensure safety and quality regulations are met, and work collaboratively with other shift leads and management to drive continuous improvement initiatives.
- Monitor production metrics and report on key performance indicators to management.
- Ensure that all documentation is completed accurately and on time.
- Participate in audits and inspections, ensuring that all regulations and standards are met.
- Managed and led a team of 50+ operators and technicians, providing guidance, training, and coaching to ensure optimal performance and productivity.
Education
Business Management
Skills
- System configuration, administration, and maintenance
- Technical issue and resolution and documentation
- User roles and access management
- InforCards, courses, workflows, vaults, and lifecycles development and execution
- Regulatory compliance analysis and implementation
- CGMP compliance inspection participation
- Positive and inclusive work environment promotion
- Proficiency in electronic document management systems such as MasterControl, SharePoint, and others
- Experienced and expertise in CFR 11 Compliance
Timeline
Compliance Manager - Vobev
07.2022 - Current
Document Control Manager - Vobev
07.2020 - 07.2022
Document Control Supervisor - Merical
10.2018 - 07.2020
Accounts Payable Specialist - Regency Excavation
10.2016 - 10.2018
Production Supervisor II - Fresenius Medical Care
03.2013 - 02.2015
Lead Senior Technical Specialist - Fresenius Medical Care
03.1998 - 02.2013
University of Phoenix - , Business Management