Ruth Ramirez-Ueda
Newbury Park,CA
Summary
Focused, dedicated and highly motivated individual with over 12 years of experience in the Biotechnology industry with strong leadership skills, problem solving skills and the ability to communicate effectively. Advanced expertise in Deviations, CAPAs, Effectiveness Verification, Change Controls, New Product Introductions, MES, Smartsheets and Inspection Readiness. Highly experienced in quality systems such as Veeva and Trackwise.
Overview
12
12
years of professional experience
Work History
Senior Specialist Manufacturing Services
FUJIFILM Diosynth Biotechnologies
Thousand Oaks, CA
04.2022 - Current
- Responsible for completing and supporting deviation investigations of complex events within Manufacturing and across other departments.
- Support department leadership in implementation of new policies, procedures and training material related to Quality Management Systems such as Investigations, CAPAs and Change Controls.
- Development of strategy to improve EBR validation time and consistency in the generation of the MBR records in MES to support NPI deliverables.
- Established collaboration within the Manufacturing departments by providing cross functional support of quality records, strategy and delivery of task.
- Coaching of staff to work thru complex investigations by reviewing and establishing GxP guidelines.
- Identified areas in need of critical improvement and implemented strategies to achieve operations readiness
- Creation of process to track and report quality metrics across the organization.
- Organize, schedule and facilitate Quality Metrics Review across the leadership of each department.
- Responsible for gathering, analyzing data to review and prevent deviations and reporting by creating monthly and quarterly trending reports for the Site.
Senior Specialist Manufacturing
Atara
Thousand Oaks, CA
04.2021 - 04.2022
- Lead and drove timely closure of complex investigations, Change Controls, CAPAs and Effectiveness Checks.
- Implemented trackers for Deviations, Change Controls, CAPAs and Effectiveness Checks to ensure timely closure of records.
- Created strategy and implementation plans for complex change controls.
- Implemented 4 squares in the development of inspection playbooks to support future audits and practice for presentation within the team.
- Helped built stability by assisting in the baseline assessment of the operations and mapping of roles for PPO role to reach future maturity plan
- Facilitated Leadership Meetings, provided meeting minutes and tracked action items.
- Cross functional collaboration to support NPI deliverables and timely closure of records.
Manufacturing Specialist
Amgen
Thousand Oaks, CA
10.2018 - 03.2021
- Organized work to meet demanding production goals.
- Owner of Major Deviation investigations for DS and DSI.
- Change Control Owner, CAPA and CAPA Effectiveness Verification Owner.
- Implementation of new system for environmental monitoring for Commercial process.
- Implementation of SQDIP, countermeasures, metrics and performance dashboard for the manufacturing plant.
- Inspection Lead for Building 7 during FDA biennial inspection and Internal audits.
- Lead of the Quality Risk Forum Meeting for Manufacturing Plant.
- Business lead for Equipment Management into Manufacturing Plant.
- Lead for Error Reduction initiative in Building 7, KYT, Pre-Job Briefing for Manufacturing and Environmental Support group.
- Implemented standard work for CAPAs, Effectiveness Verification and Change Controls.
- New Product Introduction Lead for Downstream operations including introduction of new technology.
- Responsible for completing Risk Assessments for the manufacturing plant and qualified to complete Failure Modes and Effects Analysis. (FMEA).
- Deviation trending analysis using intelligent tool.
Senior Quality Assurance Associate
Amgen
Thousand Oaks, CA
09.2017 - 10.2018
- Batch Record Review of Production Records including Master Inspection Characterization (MIC) for Lot Disposition.
- Established GxP guidelines with Data Integrity review using source for batch record review.
- Room Prep experience as Processor, Quality Control and Runner during inspections such as Partner, FDA and Internal audits.
- Closed Deviations and CAPAs.
- Pi Trend and Delta V review.
- EBR validation and revisions approval as QA.
- Generated standard work to support verification of MIC activities and Batch Record Review.
- Reduction of Cycle Time for MIC completion from 32 days to 16 days.
Manufacturing Senior Associate
Amgen
Thousand Oaks, CA
08.2010 - 09.2017
- Project Manager for MBR use in Clinical/Commercial Plant at Amgen.
- Mastery in MES Werum as an MBR Editor
- Implemented the use of Electronic Batch Records for media, buffer batch, and main product process in the clinical / commercial facility.
- Trainer in MES for Manufacturing staff, Supervisors, MBR Editors and Quality Assurance.
- Provided support to the Business Process Owner MES team during validation and system upgrades.
- Collaborated with commercial sites in development of EBR templates as part of the Amgen Global Network
- Established best practices in the use of EBR in the manufacturing environment.
- NPI lead for Upstream processes for Clinical/Commercial molecules.
- Process SOP instructions generation
- BOM creation and management in collaboration with material management
- Sample Plan creation
Education
Bachelor of Science - Microbiology
Sistema Universitario Ana G Mendez - Universidad Del Este
Carolina, PR06.2008
Skills
- Strategic Planning
- Risk Management
- Project Management
- Communication
- Analysis of Data
- Deviation Trending and reporting
- Teamwork
- Leadership
- Operational Excellence
- Mentoring of staff
Languages
Spanish
Native or Bilingual
Timeline
Senior Specialist Manufacturing Services
FUJIFILM Diosynth Biotechnologies
04.2022 - Current
Senior Specialist Manufacturing
Atara
04.2021 - 04.2022
Manufacturing Specialist
Amgen
10.2018 - 03.2021
Senior Quality Assurance Associate
Amgen
09.2017 - 10.2018
Manufacturing Senior Associate
Amgen
08.2010 - 09.2017
Bachelor of Science - Microbiology
Sistema Universitario Ana G Mendez - Universidad Del Este
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