Elmer J. Rivera
- Role
- Director of Quality Assurance at SHL Medical
- Location
- Oakland, FL, US
- LinkedIn followers
- 500 followers
About Elmer J. Rivera
Senior Quality Assurance professional with over 26 years in the Pharmaceutical and…
Experience
Director of Quality Assurance
Jun 2023 — Present
Responsible for the overall responsibility for compliance to all applicable regulations pertaining to all operations functioning on the assigned site as well as corporate compliance to all applicable regulations including cGMP pertaining to all the markets currently served by the operations functioning on the assigned site. AsI the lead quality assurance function for the respective quality system/site, actively provide guidance to multiple departments and site regarding compliance to all applicable SHL Corporate Quality and Regulatory procedures, including applicable Agency policies and regulations. Directly involved in the establishment of corporate procedures and ensure that products and/or materials are tested/released strictly under cGMP conditions and disposition is taken on time as per the committed Production Plan of every month and/or procedural requirements. Responsible for the follow up on total quality activity to ensure that the organization’s quality system comply with all relevant standards, regulations, licenses and certifications ensuring products and services are conforming to specifications; meet internal and external quality expectations.
Education
American Military Academy
High School Diploma
1983 — 1990
Louisiana State University
Entrepreneur Course, Business Administration and Management, General
2012 — 2012
University of Phoenix
Master of Business Administration (M.B.A.), Management Information Systems, General
1998 — 2001
Norwich University
Bachelor of Science (B.S.), Computer Engineering
1990 — 1995
Skills
- Project Management
- Program Management
- Microsoft Word
- Change Control
- Cross-Functional Team Leadership
- Sop
- Team Leadership
- Computer System Validation
- Gamp
- Capa
- Gmp
- Trackwise
- Data Analysis
- Software Documentation
- Regulatory Requirements
- Management
- Lims
- Fda
- Risk Management
- 21 Cfr Part 11
- Leadership
- Change Management
- Regulatory Affairs
- Lean Manufacturing
- Pharmacovigilance
- Microsoft Excel
- Policy
- Organizational Development
- Quality System
- Process Improvement
- V&V
- Project Planning
- Training
- Validation
- Six Sigma
- Government
- Regulatory Submissions
- Quality Assurance
- Customer Service
- Microsoft Office
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