Sabrina Ruiz
San Diego,CA
Overview
8
8
years of professional experience
1
1
Certification
Work History
Quality Assurance Associate II
PCI San Diego, Inc.
San Diego, CA
05.2023 - Current
- Reviews and approves the release of Media, Clinical, PPQ, and Commercial production batch records and associated data in support of cGMP operations activities and product disposition (e.g. logbooks, cleaning logs, sterilization records, stability reports, media fill records).
- Develops, revises, reviews, and approves controlled documents including SOPs, Master Batch Records, analytical methods and protocols (QCQs), and validation documentations.
- Performs internal as well as supports client and regulatory audits.
- Aseptic gown qualified to support cGMP activities (e.g. Pre-Line/Post-Line verification, Visual Inspection, and AQL performance) in sterile suites.
- Generates batch disposition paperwork such as Certificate of Compliance and BSE/TSE Statements.
- Attends weekly client meetings as QA representative for batch disposition of various Phase I-III projects.
- Manages on-site Document Control of executed Batch Records and archival to offsite location.
- Appointed SME, oversees Stability Report Review, and responsible for QA Stability Review training of new team members.
Quality Control Analyst
Custom Converting Inc.
Oceanside, CA
05.2020 - 04.2023
- Performed production reviews and First Article inspections for adherence to cGMP regulations and company quality control standards.
- Verified SOPs and audited paperwork prior to the start of every job to ensure accuracy and fluidity.
- Inspected finished product design specifications through work instructions and use of measuring tools such as calipers and optical loupes.
- Analyzed quality and performance data which was presented at weekly production meetings to support operational decision-making.
Machine Technician
Custom Converting Inc.
San Diego, CA
06.2018 - 05.2020
- Read work orders and communicate with coworkers in order to verify conformance to specifications and determine equipment settings.
- Conducted routine maintenance and inspections to identify and address mechanical issues as they occurred.
- Performed visual inspections to root out tolerance and compliance issues and maintain high-quality final products.
- Consistently reached daily/weekly quotas and completed jobs under strict deadlines.
Education
Bachelor of Arts - Comparative International Studies
San Diego State University
San Diego, CA05-2022
Skills
- Microsoft O365 Products – Outlook, Word, Excel, PowerPoint and Teams
- Data Analysis / Report Development
- Quality Control Standards – ISO 55000 / 55001 / 55002 Assessments, and Deliverables Verification
- Project Schedule Management
- Strong Communication and Interpersonal Skills
- Quality Assurance / Document Control
- BMRAM / ACE / LIMS / QAD
- ISO 5 Sterile Gown Qualification
- Batch Record Review/Disposition Qualification
- Lean Six Sigma Green Belt Certification
Certification
120-Hour TEFL Master Certificate - Bridge Education Group
Lean Six Sigma Green Belt - UCSD Extended Studies
Languages
English
Native or Bilingual
Japanese
Professional Working
Spanish
Limited Working
Timeline
Quality Assurance Associate II
PCI San Diego, Inc.
05.2023 - Current
Quality Control Analyst
Custom Converting Inc.
05.2020 - 04.2023
Machine Technician
Custom Converting Inc.
06.2018 - 05.2020
Bachelor of Arts - Comparative International Studies
San Diego State University