Laura G. Bermudez Cotto
Guayama, PR,PR
Summary
Dynamic Manufacturing Process Specialist with proven expertise at Johnson & Johnson Innovative Medicine. Skilled in ensuring compliance with cGMP regulations while effectively managing production schedules. Bilingual communicator with strong analytical abilities, adept at prioritizing tasks and leading teams to enhance productivity in high-pressure environments.
Overview
12
12
years of professional experience
1
1
Certification
Work History
Manufacturing Process Specialist
Johnson & Johnson Innovative Medicine
04.2022 - Current
- Work together with the planner to assign materials and components to process orders and organize the production plan efficiently.
- Coordinates and executes manufacturing activities according to manufacturing schedule.
- Perform review of procedures, batch records and forms to assure update with current practice in the inspection and packaging area.
- Verify the components in the plan, do Transfer Orders, and communicate daily with warehouse staff for the dispatch of materials.
- Generates Batch Records, labels and all applicable documentation from systems.
- Audit and approve the executed batch records in order to ensure compliance with established procedures, documentation requirements and cGMPs regulations.
- Perform review of procedures, batch records and forms to assure update with current practice in the inspection and packaging area.
Packaging Coordinator
N&CS Consulting Group, Inc. at Janssen-Cilag
05.2018 - 04.2022
- Same job description as now, the difference is that before it was under a contracting company.
Batch Record Reviewer; Manufacturing Operator
Kelly Services at Janssen Cilag
05.2016 - 05.2018
- Check daily that the logbook and batch record documentation is correct.
- Perform manual and semiautomatic visual inspection of parenteral lyophilized products.
- Bulk packaging of fill unlabeled parenteral product.
- Cleaning and disinfection of functional work areas.
- Audit and approve the executed batch records in order to ensure compliance with established procedures, documentation requirements and cGMPs regulations.
Packaging Technician I (Line Leader)
Vetbuilt Services Inc. at Pfizer Consumer Healthcare
08.2013 - 09.2015
- Responsible for crew distribution to daily tasks.
- Train new employees to run the packaging line area.
- Execute AQL inspections, inline
- Review that the documentation is correct, perform daily activity report and shift change
- Certified to give and discuss SOP’s and OJT to employees.
Education
Bachelor in Engineering - Civil Engineering
University of Puerto Rico, Mayagüez Campus
Mayaguez, PR05-2013
Skills
- Bilingual communication skills
- Analytical and problem-solving expertise
- Effective time management skills
- Strong communication skills
- Productivity in high-pressure environments
- Ability to prioritize tasks
- Leadership and initiative
Certification
Yellow Belt Certification
Accomplishments
- Help in the inspection batch record improvements to reduce human errors.
- Involved in the project to reduced the complete changeover time in packaging lines.
Timeline
Manufacturing Process Specialist
Johnson & Johnson Innovative Medicine
04.2022 - Current
Packaging Coordinator
N&CS Consulting Group, Inc. at Janssen-Cilag
05.2018 - 04.2022
Batch Record Reviewer; Manufacturing Operator
Kelly Services at Janssen Cilag
05.2016 - 05.2018
Packaging Technician I (Line Leader)
Vetbuilt Services Inc. at Pfizer Consumer Healthcare
08.2013 - 09.2015
Bachelor in Engineering - Civil Engineering
University of Puerto Rico, Mayagüez Campus
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