JOHANNA A GARCIA RODRIGUEZ
Cayey
Summary
Results-driven professional with a successful background in the pharmaceutical and medical device industry. Skilled in sterilization, microbiological quality assurance, product and method transfer, and equipment and method validations protocol development and execution. Proficient in USP, EP, ISO, and ANVISA regulations. Proven ability to lead investigations, CAPA, and continuous improvement initiatives. Experienced in coordinating regulatory audits (FDA, BSI, TUV, DEKRA) in the Global Operation Area. Strong expertise in QA, microbiology laboratory, compliance, and sterilization process. Recognized as the global sterilization process owner and subject matter expert.
Overview
25
25
years of professional experience
Work History
SR Manager Quality Programs Global QA
CooperVision
10.2021 - Current
- Accountable for the management of Sterility asssurance ad microbiological quality for Global Operations Processes servicing American manufacturing operation (AMO) and European Manufacturing Operation (EU) (e.g
- Manage and direct a team of professionals within the manufacturing/quality system functions based at operation sites for sterilization and microbial process control
- The primary Quality liaison between CV and the RA Group to provide feedback with registrations, submissions (510(k) / PMA, assuring that the proper information is supplied in a timely manner
- Serve as an interface between sites for the execution of protocols, projects/validations related to new products, new process, products/process design changes or process that impacted sterilization process and its related process (e.g bioburden , environmental control, water system, gowning
- Leads external and internal audit related to sterilization and microbial control for global group
- Provide direction and guidance for the sterilization process projects protocols and validation
- Assure compliance with procedures, GMP’s, international standards (ISO, MDSAP, MDR etc.) and regulatory agencies/bodies requirements (FDA, TUV SUD, CVJ etc.)
- Coordinates, executes, and oversees projects or special test related to sterilization as needed at global level
- Provide support and guidance as a subject matter expert (SME) in GTIG and Design projects
- Leads and coordinate standardization of the sterilization process and supporting process (bioburden, environmental control, water system, gowning etc.)
- Provide direction, execution, and guidance in global risk assessment and ECO’s
- Project leader for the creations and implementation of Sterility Assurance Standardization Program for global operation of global process
Principal Scientist
CooperVision
05.2016 - 10.2021
- Responsible for Sterilization Process, sterilization validation, Parametric release parameters monitoring to assure compliance and strengthening of Sterilization Program
- Responsible for the strategy and delivery of the project in the laboratory area
- Subject Matter Expert for the QA laboratories and sterilization for CooperVision sites (Global Group, Puerto Rico, and Costa Rica)
- Support developing the laboratories budget including capital and assure to comply with the approved budget and capital for new projects
- Team member of the back room during the regulatory and compliance audits for the CooperVision Americas Manufacturing Operations
- Responsible for the technical support, changes, investigations, risk assessment at CooperVision Costa Rica & Puerto Rico QA Laboratories
- (This includes calls with the sites and face to face meetings)
- Participates in regulatory Global for documents of external origins
- Responsible to provides information related to Microbial Control Process (environmental and sterilization) at Global and Local Management Review Meetings
- Responsible for the planning and coordination of the QA Laboratory projects (Microbiology, Chemistry and Formulation)
- Supervision of all technical and/or operational activities of staff members assigned to laboratories projects
- Responsible for laboratories non-conformance (NC) and CAPA investigations
- Responsible for laboratory improvements
- Assuring Compliance with Laws & Regulations
- Reviewing/Approving SOP Changes, Lab Investigations, NCR’s, CAPA’s and CAL/PM, Validation Reports, Engineering Change Orders (ECO), Risk Assessment and Trending reports
- Successfully lead manufacturing projects with budgets, including transfers from domestic and international manufacturing plants
- Work with suppliers and contractors during purchasing, installation and commissioning of equipment or services
- Manage the development and review of validation protocols for new and existing equipment and processes
- Lead Risk Assessment activities
- Author and distribute Engineering Change Orders (ECO’s)
- Generate Standard Operating Procedures (SOP’s) for new equipment and/or process
- Manage the execution of validation protocols (IQ/OQ/PQ)
- Provide training to laboratory QA laboratory personnel, ensuring transfer of critical technical knowledge in sterilization
- Plan, coordinate and execute equipment installation and annual sterilization process qualification
Senior Scientist
CooperVision
11.2013 - 05.2016
- Responsible for Sterilization Process, sterilization validation, Parametric release parameters monitoring to assure compliance and strengthening of Sterilization Program
- Subject Matter Expert for the QA laboratories and sterilization for CooperVision sites (Puerto Rico, and Costa Rica)
- Created technical and research documents such as environmental impact reports, environmental and product sampling plan
- Responsible for method development and improvement
- Evaluate and investigate Microbiology out of specification results
- Develop and improve laboratory test method
- Writes and execute validation documentation (protocols)
- Develop Actions to improve Quality KPI's
- Laboratory Manager duties such as budget and personnel supervision
- Reviewing/Approving SOP Changes, Lab Investigations, NCR’s, CAPA’s and CAL/PM, Validation Reports, Engineering Change Orders (ECO), Risk Assessment
- Manage the development and review of validation protocols for new and existing equipment and processes including laboratory and sterilization area
- Lead Risk Assessment activities
- Author and distribute Engineering Change Orders (ECO’s)
- Generate Standard Operating Procedures (SOP’s) for new equipment and/or process
- Manage the execution of validation protocols (IQ/OQ/PQ)
- Provide training to laboratory manufacturing personnel, ensuring transfer of critical technical knowledge
- Plan, coordinate and execute equipment installation
- Responsible for the transfer a new process from the CooperVision Facilities Hungary to CooperVision Costa Rica: New procedures, lead the startup of the QA laboratory area (Chemistry and Microbiology), support the activities of the start-up process for the Manufacturing Laboratory Area, equipment acquisition, equipment installation, validation of equipment employee recruitment and training laboratory supervisor
- Responsible for the development of the new procedures, risk assessments, validation reports and the documentation related to the ECO's (engineering change orders) for the sterilization process
- Responsible for the laboratories design and construction of these new areas
QC Technician
Becton Dickinson
03.2010 - 11.2013
- Responsible of startup, implementation, and daily works of the new laboratory area
- Responsible for product transfer from Baltimore, MD to PR facility
- Responsibilities: Incoming Lab - Raw material sampling, testing and disposition
- Product and process trouble shooting
- Chemistry Lab – Analytical and microbial methods for material and final products analysis
- Review and disposition of final product
- Responsible for laboratory investigations
- Procedures development
- Responsible for stability program, scheduling, and testing
- Ensures manufacturing plans and quality goals are met
- Assuring Compliance with Laws & Regulations
- Reviewing SOP Changes
- Generate Standard Operating Procedures (SOP’s) for new equipment and/or process
- Manage the execution of validation protocols (IQ/OQ/PQ)
Senior Microbiologist Consultant
ReComs
02.2008 - 12.2008
- Responsible to works as microbiology expert in a third-party laboratory operation
- Responsible for method development, troubleshooting and problem solving in the microbiology area for the client (pharmaceutical and medical device)
- Responsibilities: Responsible for method developing and method qualification
- Leader of the implementation of microbial methods, new sampling process, new procedures, new laboratory setup / equipment and supplier management
- New procedures, and translation, new process, raw materials technical knowledge, equipment acquisition, equipment installation, validation of equipment/mixing process
- Responsible for the development of the new procedures, risk assessments, validation reports and the related documentation
- Support and approval of quality investigation
- Work as a liaison between QA department and the client
- Develop and present project proposal
- Successfully lead projects within budget, scope, and planned schedule
Quality Control Microbiology Laboratory Supervisor
Patheon/ Mova Pharmaceutical Copr
11.2003 - 11.2007
- Responsible for the QA Microbiology laboratory
- Subject matter expert in sterilization, method development, environmental control, sterility and aseptic process
- The QA microbiology laboratory have a team of 15 members (exempt 10 and technician)
- Responsible for Laboratory investigations
- Generate and review Standard Operating Procedures (SOP’s)
- Manage the execution of validation protocols (IQ/OQ/PQ)
- Provide training to laboratory microbiology personnel, ensuring transfer of critical technical knowledge
- Supervision of all technical and/or operational activities and staff members in the laboratories
- Responsible for laboratory improvements
- Budgeting
- Interview, hire, planning, assigning, and directing work; appraising performance; rewarding and disciplining employees, addressing complaints, and resolving problems
Quality Compliance officer
Novartis
05.2000 - 11.2003
- Approval and revision of the validation documents related to manufacturing and laboratory process
- Maintain quality system such as investigations and complaints
- Perform internal and external audits
- Perform product registration to Latin America and Foreign regions
- Perform the annual product review of the product
- Work as liaison and coordinator during the regulatory inspection including FDA and MCA agency
- Review and approve standard operating procedure in accordance with organization policy and modules
Education
BACHELOR DEGREE - Concentration in Industrial Microbiology, minor in Chemistry
University of P.R. – Mayaguez Campus
MBA - Project Management
Universidad Isabel I
Spain07-2023
Skills
- Leadership Experience
- Effective Communication
- Collaboration Skills
- Fluent in English and Spanish
- Strategic Prioritization
- Strategic Decision Making
- Expertise in Microsoft Office
- Project Management Seminars
Training Seminars
- Lean Six Sigma Yellow Belt Certification.
- Project Management- PMI.
- CAPA for the FDA- Regulated Industry- Business Excellence Consulting.
- Certified medical device and pharmaceutical expert- Business Excellence Consulting.
- PDA Sterilization Tech Report No.1.
Affiliations
- Sterility Assurance Professionals
- PDA
- AAMI
Timeline
SR Manager Quality Programs Global QA
CooperVision
10.2021 - Current
Principal Scientist
CooperVision
05.2016 - 10.2021
Senior Scientist
CooperVision
11.2013 - 05.2016
QC Technician
Becton Dickinson
03.2010 - 11.2013
Senior Microbiologist Consultant
ReComs
02.2008 - 12.2008
Quality Control Microbiology Laboratory Supervisor
Patheon/ Mova Pharmaceutical Copr
11.2003 - 11.2007
Quality Compliance officer
Novartis
05.2000 - 11.2003
BACHELOR DEGREE - Concentration in Industrial Microbiology, minor in Chemistry
University of P.R. – Mayaguez Campus
MBA - Project Management
Universidad Isabel I
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