Quality Compliance
ROBERT RODRIGUEZ-ANDUJAR
Amgen
Moorpark,CA
30
years of professional experience
10
year of post-secondary education
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.
Work History
Process Development Manager
4 Years 6 Months- 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
8 Months- 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
6 Years 2 Months- 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
Amgen Investigation And Human Errors Certification - Investigation
Project Management Certification - Project Management
Master - Technology Management
Doctor of Philosophy - Microbiology & Molecular Genetics
Bachelor of Sciences - Biology
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
American Society For Quality
Ceruified Quality Auditor from Quality
08.2024 - 12.2024Read More
Business Excellence Consulting
Amgen Investigation And Human Errors Certification from Investigation
05.2024 - 07.2024Read More
Process Development Manager
Amgen
04.2022 - CurrentRead More
Quality Assurance Specialist
Amgen Manufacturing Limited
08.2021 - 04.2022Read More
Senior Regional Ethics & Compliance Manager
Walmart USA
09.2013 - 11.2019Read More
Project Management Institute
Project Management Certification from Project Management
Read More
STEVENS INSTITUTE OF TECHNOLOGY
Master from Technology Management
Read More
RUTGERS UNIVERSITY
Doctor of Philosophy from Microbiology & Molecular Genetics
Read More
UNIVERSITY OF PUERTO RICO
Bachelor of Sciences from Biology
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