Angel Lopez
Senior Quality Assurance Supervisor
Anaheim,CA
Summary
Results-driven Senior Quality Assurance Supervisor with a strong background in Biopharmaceutical manufacturing and compliance. Proven expertise in leading investigations, CAPA planning, and driving compliance with cGMP regulations. Skilled in optimizing QA efficiency, fostering continuous improvement, and achieving operational excellence.
Overview
7
7
years of professional experience
9
9
years of post-secondary education
Work History
Senior Quality Assurance Supervisor
Octapharma Plasma, Inc.
Van Nuys, CA
02.2021 - Current
- Developed, implemented, and maintained Quality Systems to ensure compliance with SOPs and regulatory requirements.
- Led investigations, root cause analyses, and CAPA planning to address internal and external audit findings, ensuring compliance with cGMP regulations.
- Acted as Subject Matter Expert for Quality and provided Root Cause Analysis training.
- Drove continuous improvement by ensuring compliance in Quality, Safety, and Training, while representing Quality on cross-functional teams.
- Identified and addressed procedure, process, and system gaps to maintain inspection readiness.
- Ensured accuracy of records and reports, including stability reports and production records.
- Represented Quality Assurance on multi-disciplinary project teams, collaborating with departments to ensure all review activities were executed efficiently per governing SOPs.
Quality Assurance Supervisor
Octapharma Plasma, Inc.
Van Nuys, CA
01.2019 - 02.2021
- Identified and addressed corrective actions, collaborating with departments to ensure efficient execution of review activities per governing SOPs
- Prepared for and co-hosted internal and external audits, ensuring compliance by reviewing and approving CAPA records in alignment with procedural and regulatory requirements.
- Analyzed tracking and trending data to determine and implement appropriate actions for continuous improvement.
- Collaborated with Donor Center Manager to complete audit responses within required time frames, ensuring accuracy of records and reports.
Quality Assurance Technician
Octapharma Plasma, Inc.
Van Nuys, CA
07.2017 - 01.2019
- Ensured compliance with federal, state, and company-specific regulations, conducting audits for self-assessment evaluation and monitoring records for compliance.
- Reviewed equipment calibration, validation, and maintenance records to ensure compliance with regulatory standards.
Education
Bachelor of Science - Business Administration
California State University, Long Beach
Long Beach, CA 09.2002 - 05.2010
Associate of Arts - Liberal Arts
Santa Ana College
Santa Ana, CA 09.2000 - 05.2002
Skills
Timeline
Senior Quality Assurance Supervisor
Octapharma Plasma, Inc.
02.2021 - Current
Quality Assurance Supervisor
Octapharma Plasma, Inc.
01.2019 - 02.2021
Quality Assurance Technician
Octapharma Plasma, Inc.
07.2017 - 01.2019
Bachelor of Science - Business Administration
California State University, Long Beach
09.2002 - 05.2010
Associate of Arts - Liberal Arts
Santa Ana College
09.2000 - 05.2002
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