ROBERT RODRIGUEZ-ANDUJAR
Quality Compliance
Moorpark,CA
Summary
Versatile Senior Manager specializing in drug product and skilled at planning, implementing and overseeing key improvements to drive business growth and efficiency. Collaborative leader with knowledge of regulatory compliance and proven track record of partnering with executives and business leaders to identify vulnerabilities and create corrective actions.
Overview
30
30
years of professional experience
10
10
year of post-secondary education
Work History
Process Development Manager
Amgen
04.2022 - Current
- Quality and compliance DPT leader managing department deviation records, CAPA and change controls. Managed DPT internal audit and oversaw responses to findings.
- Collaborate with company leaders to support consistency and best practices.
- Create new methodologies to improve planning process and results.
- Monitor processes and procedures, making sure company met compliance regulations.
- Lead cross-functional teams to develop and implement strategic project plans.
- Streamline development processes, improving efficiency and reducing lead times.
Quality Assurance Specialist
Amgen Manufacturing Limited
08.2021 - 04.2022
- Increase compliance culture at AML by providing compliance advice and employee training in Environmental Management and Occupational Safety, OSHA, Fire Code, and Health Safety.
- Recorded findings of inspection process, collaborating with quality team to implement corrective actions.
- Analyzed quality and performance data to support operational decision-making.
- Completed over 25 minor deviation forms and collaborated with site quality team members and department managers to implement procedural remedies.
Senior Regional Ethics & Compliance Manager
Walmart USA
09.2013 - 11.2019
- Applied safety and occupational health laws, regulations, principles, theories, practices, and procedures to advise on or resolve technical matters dealing with occupational safety and health requirements at over 40 locations in Puerto Rico.
- Developed corrective action plans to secure enterprise-wide internal controls for safety and environmental compliance and recommended safety and occupational health policy to higher levels of management.
- Identified root cause of compliance exceptions and assessed compliance risks to support plan development and implementation by managers comprising over 12,000 employees.
- Improved ethic and compliance culture of region through strategic motivation and employee coaching.
- Developed and implemented compliance training programs for associates, enhancing understanding of regulatory requirements.
- Conducted regular audits and assessments to ensure adherence to internal policies and government regulations.
Education
Ceruified Quality Auditor - Quality
American Society For Quality
08.2024 - 12.2024
Amgen Investigation And Human Errors Certification - Investigation
Business Excellence Consulting
Thousand Oaks 05.2024 - 07.2024
Project Management Certification - Project Management
Project Management Institute
Guaynabo, PR03.2017
Master - Technology Management
STEVENS INSTITUTE OF TECHNOLOGY
Hoboken, NJ06.2000
Doctor of Philosophy - Microbiology & Molecular Genetics
RUTGERS UNIVERSITY
New Brunswick, NJ09.1994
Bachelor of Sciences - Biology
UNIVERSITY OF PUERTO RICO
Rio Piedras, PR06.1988
Skills
- Quality Management
- Project Management
- Corrective actions
- Critical Thinking
- Internal Audits
- Compliance Requirements
- Strategic Planning
- Management Experience
- Cross-Functional Communication
- Problem-Solving Skills
- Life Sciences
- Research And Development
- Collaborate Cross-Functionally
Languages
Spanish
Native or Bilingual
Timeline
Ceruified Quality Auditor - Quality
American Society For Quality
08.2024 - 12.2024
Amgen Investigation And Human Errors Certification - Investigation
Business Excellence Consulting
05.2024 - 07.2024
Process Development Manager
Amgen
04.2022 - Current
Quality Assurance Specialist
Amgen Manufacturing Limited
08.2021 - 04.2022
Senior Regional Ethics & Compliance Manager
Walmart USA
09.2013 - 11.2019
Project Management Certification - Project Management
Project Management Institute
Master - Technology Management
STEVENS INSTITUTE OF TECHNOLOGY
Doctor of Philosophy - Microbiology & Molecular Genetics
RUTGERS UNIVERSITY
Bachelor of Sciences - Biology
UNIVERSITY OF PUERTO RICO