IRENE OROPEZA
Summary
Dedicated and adaptable professional demonstrating high level of ownership and initiative. Capable of managing projects and collaborating effectively with teams. Committed to continuous learning and staying current with industry standards and regulations to contribute to organizational success. Ability to lead teams towards maintaining operational integrity and minimizing risk, ensuring high standards of compliance are achieved and maintained.
Overview
31
31
years of professional experience
Work History
Manager, Quality Operations Finished Product
Grifols Biologicals LLC
City of Industry, CA
01.2019 - Current
- Defined clear responsibilities and roles for staff members to ensure smooth operations in the QO Finished Product department.
- Contributed to the successful completion of Packaging and 100% Visual Inspection Operations, meeting the scheduled deadlines.
- Conducted investigations to identify the cause of product damage, distribution issues, and customer complaints.
- Created monthly reports for senior management summarizing operational performance metrics and identified areas of improvement.
- Ensured compliance with regulatory requirements and industry standards for all packaged products.
- Streamlined communication channels, improving information flow and decision-making speed.
Manager, Quality Assurance Documentation
Grifols Biologicals LLC
Los Angeles, CA
01.2006 - 01.2019
- Successfully ensured compliance and efficient management of all documents for multiple GB departments in the role of Business Administrator of Documentum Compliance Manager (DCM).
- Oversaw the preparation and distribution of weekly reports through Oracle Discoverer, ensuring accurate tracking of document statuses in DCM. Additionally, monitored and reported compliance from departments on overdue items and upcoming periodic reviews for procedures.
- Collaboratively led team meetings to evaluate and finalize plant change requests, ensuring all required documents were acquired for implementation.
- Delivered high-quality annual product review reports to regulatory agencies, showcasing detailed information regarding equipment upgrades, process enhancements, utility advances, and facility changes across all product lines.
- Managed customer communication regarding changes with Instituto Grifols and Grifols Therapeutics
Manager, Quality Assurance Environmental Monitoring
Grifols Biologicals, LLC
Los Angeles, CA
01.2001 - 01.2006
- Enhanced operational efficiency by effectively managing personnel engaged in QAEM for Aseptic Filling, Bulk Manufacturing, Water System, and Compressed Gases at GB.
- Played a role in developing and administering objectives, policies, and the departmental budget for the EMQA program.
- Developed and implemented study protocols, effectively summarizing data results for final reports. Executed assigned special projects and investigations.
- Reported environmental monitoring results and conducted investigations for excursions.
- Developed and revised Quality and Laboratory Standard Procedures ensuring compliance with GMP/GLP regulations and industry standards.
- Played a pivotal role in supporting and ensuring successful regulatory agency inspections, leading to favorable audit outcomes.
Supervisor, Quality Control Environmental Monitoring
Alpha Therapeutic Corporation
Los Angeles, CA
01.1998 - 01.2001
- Managed the selection and distribution of daily routine monitoring tasks; Provided personnel support for aseptic product fills and additional operations.
- Demonstrates a deep understanding of Laboratory Information Management System (LIMS), successfully navigating the processes of logging data, entering information accurately, and approving environmental monitoring measurements. Proficient in generating insightful LIMS reports.
- Conducted laboratory studies, compiling and summarizing data findings into comprehensive final reports.
- Evaluated EM results, handled failure investigations relating to out of specification findings, and documented data in final reports for management.
- Handled procurement and upkeep of supplies essential for environmental monitoring.
Validation Engineer
NeXstar Pharmaceuticals, Inc.
San Dimas, CA
01.1994 - 01.1998
- Ensured successful qualification of 44 controlled rooms with varying levels of cleanliness and utility systems required for facility start-up.
- Conducted clean room certifications by utilizing Particle Counters, Viable Air Samplers, and acquiring surface samples through media plates/swabs
- Developed and executed IQ/OQ/PQ protocols for various pharmaceutical equipment such as incubators, autoclaves, and lyophilizers. Also conducted data analysis and prepared final reports.
- Analyzed EM results and conducted failure investigations on nonconforming outcomes, presenting findings in comprehensive reports for management evaluation.
- Demonstrated expertise in training Validation and Manufacturing personnel on aseptic gowning and cleaning of classified areas.
Education
Masters - Business Administration
University of Phoenix
Ontario01.1999
Bachelor of Science - Biology
University of California, Riverside
Riverside01.1993
Skills
- Cross-Functional Teamwork
- Verbal and Written Communication
- Team Leadership
- Staff Management and Development
- Quality Management Systems
- Operations Management
- Compliance Monitoring
- Regulatory Compliance
Accomplishments
- Participant of Cohert 2 Talent Program (2023-2024)
- Outstanding Performance Recognition Awards (DEC 2023 and May 2024)
Timeline
Manager, Quality Operations Finished Product
Grifols Biologicals LLC
01.2019 - Current
Manager, Quality Assurance Documentation
Grifols Biologicals LLC
01.2006 - 01.2019
Manager, Quality Assurance Environmental Monitoring
Grifols Biologicals, LLC
01.2001 - 01.2006
Supervisor, Quality Control Environmental Monitoring
Alpha Therapeutic Corporation
01.1998 - 01.2001
Validation Engineer
NeXstar Pharmaceuticals, Inc.
01.1994 - 01.1998
Masters - Business Administration
University of Phoenix
Bachelor of Science - Biology
University of California, Riverside
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