Glorysela Gonzales
Escondido,CA
Summary
Results-driven Manufacturing Associate with extensive experience in cGMP environments, specializing in biologic product formulation, equipment operation, and quality control. Strong documentation skills and meticulous attention to detail ensure accuracy and compliance throughout all production processes. Proven ability to train and mentor team members, enhancing overall efficiency while upholding stringent bio-decontamination standards. Equipped with excellent analytical, communication, and teamwork skills, ready to adapt swiftly to new challenges and contribute positively to team success while pursuing continuous professional development.
Overview
24
24
years of professional experience
Work History
Manufacturing Technician
Solved Health
01.2024 - 08.2025
- Execute cGMP production processes, ensuring compliance and high-quality output, improving product reliability.
- Formulate and Process reagents and manufacture genetic tests in ISO cleanroom, enhancing production efficiency.
- Review and execute documentation based on cGMP and GDP procedures, ensuring accuracy and compliance.
- Conduct regular cleaning of manufacturing areas and equipment to meet industry standards.
- Record batch data, verifying product specifications and compliance.
- Stock manufacturing rooms with necessary materials, maintaining continuous production flow.
- Manage NetSuite transactions, inventory control, issue materials, and close work orders efficiently, optimizing resource management.
Manufacturing Associate III
Argonaut Manufacturing Services
01.2023 - 01.2024
- Execute cGMP production processes, ensuring compliance and high-quality output, improving product reliability.
- Formulate liquid assays and create lyophilized products in ISO cleanroom, enhancing production efficiency.
- Review and execute documentation based on cGMP and GDP procedures, ensuring accuracy and compliance.
- Train new team members, increasing team efficiency and knowledge in production activities.
- Manage NetSuite transactions, issue materials, and close work orders efficiently, optimizing resource management.
Manufacturing Associate II
Capricor Therapeutics
01.2022 - 01.2023
- Guided operators on cGMP documentation, enhancing compliance and operational efficiency.
- Analyzed data and reported abnormalities, maintaining high production standards.
- Authored and revised SOPs, improving workflow consistency.
- Managed inventory and cleanroom activities, ensuring seamless cGMP operations.
- Streamlined biologic product manufacturing, enhancing efficiency in media preparation and cell culture.
Manufacturing Technician III
Tissue Regenix
01.2019 - 01.2021
- Processed and packaged human tissue in aseptic GMP environment, ensuring safety and compliance.
- Managed inventory using AS400, optimizing order fulfillment and reducing errors.
- Collected QC lab samples, contributing to quality assurance and regulatory standards.
- Assisted with cross-departmental processes, enhancing overall operational efficiency.
- Handled aseptic GMP processes for human tissue, ensuring quality control through sample collection.
Manufacturing Technician II
Cytori Therapeutics
01.2018 - 01.2019
- Manufactured chemotherapy medication for breast and ovarian cancer patients, ensuring quality and safety.
- Collaborated with process engineers on studies and IQ/OQ validations, enhancing procedural accuracy.
- Received, inspected, and quarantined raw materials, ensuring compliance with QC standards.
- Collected samples for QC lab testing, facilitating timely release of materials for manufacturing.
- Managed administrative tasks including filing, inventory control, and ordering supplies, ensuring operational efficiency.
- Authored and updated specification and inspection forms, standardizing documentation across departments.
- Stocked manufacturing rooms with necessary materials, maintaining continuous production flow.
- Performed daily and weekly cleaning of manufacturing clean rooms and equipment, upholding hygiene standards.
- Assisted QC in material inspection processes, supporting timely quarantine and release of materials.
- Supported laboratory duties, contributing to overall lab efficiency and productivity.
Manufacturing Technician I
Globus Medical
01.2017 - 01.2018
- Processed and packaged human tissue in an Aseptic GMP environment, ensuring surgical and dental safety.
- Trained in Amnion processing and packaging, contributing to high-quality manufacturing standards.
- Conducted daily and weekly cleaning of manufacturing rooms and equipment, maintaining sterile conditions.
Manufacturing Technician
BioMerieux
01.2016 - 01.2017
- Processed and manufactured infectious disease testing pouches in a GMP environment, ensuring timely daily operations and maintaining high-quality standards.
- Operated multiple packaging and array lines in GMP environment, ensuring timely production of infectious disease testing pouches while adhering to strict quality standards.
- Streamlined manufacturing processes for testing pouches, boosting efficiency and meeting production targets consistently in a fast-paced biotech setting.
- Monitored and analyzed production metrics, identifying areas for improvement in pouch processing and implementing data-driven solutions to enhance output.
Manufacturing Technician III
Allergan Pharmaceuticals
01.2007 - 01.2016
- Operated multiple packaging lines and equipment, ensuring compliance with CGMP and GMP practices.
- Trained employees on batch records, new processes, and equipment, enhancing team efficiency.
- Collaborated with R&D and engineers to test and implement new packaging processes and equipment.
- Manufactured various transdermal patches, maintaining product quality and specifications.
- Conducted regular cleaning of manufacturing areas and equipment to meet industry standards.
Manufacturing Technician II
Cephalon, Inc
01.2002 - 01.2007
- Operated multiple packaging lines, ensuring adherence to CGMP and GMP standards.
- Diagnosed and resolved equipment issues, minimizing downtime and maintaining production flow.
- Recorded batch data, verifying product specifications and compliance.
- Handled dispensing, blending, and formulation processes, ensuring quality and consistency.
- Collected raw material samples for QC testing, facilitating timely product release.
- Conducted regular cleaning of clean rooms and equipment, maintaining a sterile environment.
Education
Diploma -
Horizonte High School
Salt Lake City, UtahAAS - Criminal Justice
Salt Lake City Community College
Salt Lake City, UtahBachelor of Science - Criminal Justice
Western New Mexico University
Silver City, New MexicoSkills
- Safety protocols
- Good manufacturing practices
- Equipment troubleshooting
- Precision assembly
Timeline
Manufacturing Technician
Solved Health
01.2024 - 08.2025
Manufacturing Associate III
Argonaut Manufacturing Services
01.2023 - 01.2024
Manufacturing Associate II
Capricor Therapeutics
01.2022 - 01.2023
Manufacturing Technician III
Tissue Regenix
01.2019 - 01.2021
Manufacturing Technician II
Cytori Therapeutics
01.2018 - 01.2019
Manufacturing Technician I
Globus Medical
01.2017 - 01.2018
Manufacturing Technician
BioMerieux
01.2016 - 01.2017
Manufacturing Technician III
Allergan Pharmaceuticals
01.2007 - 01.2016
Manufacturing Technician II
Cephalon, Inc
01.2002 - 01.2007
AAS - Criminal Justice
Salt Lake City Community College
Bachelor of Science - Criminal Justice
Western New Mexico University
Diploma -
Horizonte High School
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