Summary
Overview
Work History
Education
Skills
Certification
Timeline
Generic

Maria Lopez

San Jose,CA

Summary

Dynamic Process Engineer with expertise in high-throughput NGS workflows at Roche Diagnostics. Proven ability to enhance operational efficiency through effective collaboration and continuous improvement initiatives. Skilled in GMP/SOP compliance and training junior team members, ensuring quality assurance and safety in regulated environments. Committed to achieving production targets while maintaining superior quality standards.

Overview

5
5
years of professional experience
1
1
Certification

Work History

Process Engineer

Roche Diagnostics (Sequencing/Reagents/DNA/RNA)
01.2024 - 07.2024
  • Execute high throughput, SOP driven, NGS library preparation workflows including WGS and RNA-Seq, with an emphasis on liquid handling automation.
  • Operate sequencing instruments.
  • Collaborate with scientists to improve current NGS workflows/processes in creative and effective ways
  • Work independently and as part of a multi-disciplinary team to solve complex problems and achieve goals/deadlines.
  • Thoroughly document and effectively communicate scientific results and progress.
  • Assist with other molecular biology tasks as needed at the scientific platform.
  • Executed the process of assembly in-line testing, cleaning and packaging of varying complexity and in accordance with production manufacturing records, operating procedure requirements to produce finished intermediates and final kits while meeting production targets.
  • Capable of basic transactions within highly complex systems and controls in a regulated manufacturing environment (e.g. receive, process, build product/materials, facilitate material availability, SAP transactions/confirmations).
  • Runs automated systems/equipment and sequences of operation, including: equipment setup, operation, and cleaning; monitoring and performing basic troubleshooting.
  • Participate in the execution of protocol/validations.
  • Ability to be a subject matter expert (SME) in one or more areas of production.
  • Contributes to daily end of shift reports and pass downs.
  • Maintain Right to Operate and ensure that all processes are performed in a safe and healthy manner; Address and escalate any potentially unsafe hazards; Provides feedback during investigation of safety hazards, incidents and near misses using safety reporting tools.
  • Perform tasks/transactions in the quality system to ensure we achieve our quality objectives.
  • Understand the expectations of audit readiness (OSHA, FDA, QSR, GMP, ISO, etc.); may be required to answer questions about processes on the spot.
  • Maintain accurate and complete system transactions ensuring material traceability, and inventory accuracy (e.g. receipt, storage, issuance of materials, and other inventory transactions)
  • Provide feedback on NCR investigations, reworks, and corrective actions.
  • Responsible for 6S activities, gathering/meeting cycle times and developing/following standard work; identifies and implements process improvements and continuous improvement initiatives utilizing lean tools.
  • Participated and contributes in tier meetings.
  • Participated in the collection of data for daily metrics purposes and to support operational excellence initiatives and improvements. Teamwork and Collaboration.
  • Proactively collaborates with peers in other shifts/functions to ensure daily targets are achieved.
  • Assist in the successful onboarding of new employees and contractors.

Junior Process Engineer

Recor Medical (Catheters)
10.2023 - 01.2024
  • Prepare & handle hazardous chemical reagents
  • Read and follow SOPs
  • Adhere to, and enforce strict safety guidelines
  • Observe, document & report on processes, problems
  • Train other personnel
  • Address production issues in a real-time manner. Collect and analyze equipment data and product data and disposition accordingly.
  • Collect and analyze data for both operational metrics and functional performance, and drive tool matching and improvements.
  • Define preventive and corrective actions to eliminate root cause of failures.
  • Develop and sustain processes, operating procedures, and related documentation.
  • Provide training to production team members on procedures and reaction plans.
  • Work in cross-functional teams with Quality, Product Development, and Manufacturing team to develop procedures and deliver efficiency improvements for manufacturing.

Jr. Process Technician

Procept Bio-Robotics (Robotic Medical Equipment Manufacturing)
11.2022 - 10.2023
  • Worked in a Clean Room Environment Mentored and Trained New Onboarding Employees.
  • Assisted newly hired team members by explaining company procedures and safety requirements.
  • Determined team assignments and work procedures to increase efficiency.
  • Perform many assembly types of functions, using hand and power tools
  • Assemble components into a completed product by following GMP and approved procedures
  • Assemble parts under a microscope using small instruments and microscopic devices
  • Perform a wide range of complex tasks involving repair and testing
  • Understood assembly processes and SOPs
  • Followed defined procedures to achieve expected Quality output
  • Recognized and communicated to Production Lead complex build difficulties and/or product faults in a clear, concise, and timely manner
  • Recognized, diagnosed and communicated routine problems
  • Worked with the R&D & Operations team to relate process improvements for changes in the Work Process instructions for Company's products
  • Interpreted assembly drawings

Manufacture Associate

Cepheid (Medical tests) (Covid tests) (Reagents/Assays)
01.2020 - 11.2022
  • Weld, prep, clean, and inspect parts before and after assembly according to guidelines
  • Worked in a clean room and help put together parts for medical testing kits
  • Worked varied hours to meet seasonal and business needs
  • Prioritized tasks to meet tight deadlines, pitching in to assist others with project duties
  • Made sure that products were produced on time and were of superior quality
  • Organized work to meet demanding production goals
  • Assembled products to meet production requirements and daily established quotas
  • Collaborated with team members to meet production deadlines
  • Monitored and adjusted machine settings for optimal production output
  • Followed safety protocols and utilized OSHA-approved PPE to foster a safe working environment
  • Utilized hand tools and machinery to safely complete assembly processes
  • Assembled products according to changing daily work orders and specific customer needs

Education

Associate of Science - Health Science

Merced College
Los Banos, CA

Bachelor of Science - Biology

School of Biological Sciences San Jose State
San Jose, CA

High School Diploma -

Los Banos High School
Los Banos

Skills

  • Assembly Processes
  • Supply Chain Distribution
  • Work Orders
  • Daily Logs
  • GMP/SOP
  • Equipment Monitoring
  • Product Assembly and Disassembly
  • Infection control standards
  • Laboratory Experience
  • Manufacturing
  • Assembly and Production
  • Testing Equipment Operation
  • Inspection Procedures
  • Materials Management
  • Hazardous Materials
  • Training Junior Team Members
  • Small Parts Assembly
  • 5S Methodology
  • Product inspection component Assembly
  • Following Procedures and Protocols
  • Teamwork and Collaboration
  • Quality Assurance
  • Product Packaging

Certification

Certified Sterile Processing Technician: Sterile Processing Distribution, Martinson College, July 2019

Timeline

Process Engineer

Roche Diagnostics (Sequencing/Reagents/DNA/RNA)
01.2024 - 07.2024

Junior Process Engineer

Recor Medical (Catheters)
10.2023 - 01.2024

Jr. Process Technician

Procept Bio-Robotics (Robotic Medical Equipment Manufacturing)
11.2022 - 10.2023

Manufacture Associate

Cepheid (Medical tests) (Covid tests) (Reagents/Assays)
01.2020 - 11.2022

Associate of Science - Health Science

Merced College

Bachelor of Science - Biology

School of Biological Sciences San Jose State

High School Diploma -

Los Banos High School

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