Laboratory Manager, Associate, GMP/GLP consultant, Pharmacy Technician

Noe Gonzales

Glendora, CA *****

************@*****.***

626-***-****

Laboratory Director/Manager/Research Facilities Research Associate A reliable and accomplished leader with comprehensive experience in management, project coordination, and laboratory oversight. Highly proactive and methodical, I am dedicated to providing exceptional service, prioritizing customer satisfaction with a strong sense of urgency. Expertise in Facilities and Laboratory Management and Maintenance Committed to adherence with Good Laboratory Practice (GLP) standards.

Project Coordination

Budget & Purchasing Management & Contract Negotiation Customer Client Service

Proven Leader

Excellent computer skills

Safety Policy & Procedures

Excellent verbal / written communication skills

Pharmacy regulations management

Pharmacy Technician

Work Experience

Regulatory Compliance Manager

Global Medical Devices - Pomona, CA

September 2022 to March 2024

Regulatory Consultant for Good Laboratory Practices (GLP) Overview: As a Regulatory Consultant specializing in Good Laboratory Practices (GLP), ensuring the organization adheres to regulatory requirements and industry standards governing laboratory practices. Provide expertise and guidance to ensure compliance with GLP regulations, maintain high-quality standards in laboratory operations, and facilitate continuous improvement initiatives. Responsibilities:

1. Regulatory Compliance:

• Stay abreast of current GLP regulations and guidelines issued by regulatory authorities such as FDA, EPA, and OECD.

• Interpret and apply GLP regulations to ensure our laboratory operations meet or exceed compliance standards.

• Conduct periodic audits and assessments to identify areas of non-compliance and implement corrective actions as necessary.

1. Documentation and Record-Keeping:

• Develop and maintain documentation procedures to ensure accurate recording of laboratory activities, data, and results in compliance with GLP requirements.

• Review study protocols, reports, and documentation to ensure completeness, accuracy, and compliance with regulatory standards.

• Provide guidance on document management systems to streamline processes and maintain audit readiness.

1. Training and Education:

• Develop and deliver training programs on GLP regulations, laboratory practices, and quality assurance principles for laboratory personnel.

• Collaborate with cross-functional teams to ensure all staff members understand their roles and responsibilities in maintaining GLP compliance.

• Monitor training effectiveness and provide ongoing support to ensure continuous improvement in compliance knowledge and practices.

1. Quality Assurance Support:

• Assist in the development and implementation of quality assurance systems and processes to ensure consistent adherence to GLP standards.

• Participate in internal and external quality audits, providing expertise and support to address findings and implement corrective actions.

• Conduct risk assessments and recommend preventive measures to mitigate potential compliance risks. 1. Continuous Improvement:

• Identify opportunities for process optimization and efficiency improvements within laboratory operations while maintaining compliance with GLP regulations.

• Collaborate with stakeholders to implement best practices and innovative solutions to enhance compliance and quality outcomes.

• Monitor industry trends and regulatory developments to anticipate changes and proactively adapt our practices and processes.

Director of Institutional Research and Laboratory Services Western University of Health Sciences - Pomona, Ca January 2017 to December 2021

Research & Biotechnology

Responsible for the activities in the research laboratories on campus overseen by the Vice President for Research and Biotechnology.

· Oversees the management and organization of institutional research space and shared equipment throughout all University Research labs

· Creates and maintains research space maps including investigator lab space allocation and metrics for review by leadership. Creates and maintains databases of all equipment throughout campus

· Fiscal planning, anticipating replacement, emergency replacements.

· Organization of equipment database to minimize redundancy of equipment and unneeded expenditures

· Maintains areas throughout campus identified as “shared equipment” for the use of all personal. These pieces include but not limited to low, high and ultra high centrifuges, imagers, cell counters, plate readers, cryogenic storage containers, sonicators, lyophilizers DI/RO water systems, compressed gas monitoring and replacement etc.

· Monitors cloud based alarm system associated with the freezer rooms, cold rooms and other critical areas. Provides after-hour services in the event of a failure in order to secure/preserve the research materials. On-call responder to all alarmed units.

· Maintains a fair and equable time schedule for multiple users; establish sign-in log sheets via electronic scheduling using MS outlook and standard sign-up sheets to minimize conflicts.

· Negotiates contracts for services from vendors and for purchasing instruments in cooperation with the purchasing department. Research instruments and compare best prices and services online.

· Ordering of supplies needed to run equipment and ensure that all equipment is used in a safe manner.

· Maintains the equipment records and manuals for reference and review.

· Maintains a log of logins and passwords for pieces of equipment that incorporate high speed centrifuges. Utilize skills to foster strong relationships among various departmental boundaries and with external vendors.

· Duty Performs the duties as the URC safety officer and communicates with campus EH&S department concerning any issues regarding the research facility.

· Functions as lead safety liaison with the Safety departments (EH&S) and is head for departmental or laboratory safety officers.

· Works with the appropriate safety officer and affected personnel in rectifying any violation found by the Safety Department. Follows up with the Safety department to ensure compliance has occurred.

· Establishes a structured chain of command and duties, maintain and implementation of an emergency evacuation and relocation safely of all personnel and irreplaceable and perishable laboratory materials.

· Performs the duties of radiation compliance officer and chemical safety officer for the research labs. Collaborates with Radiation Safety Officer and Chemical Safety Officer by monitoring and assisting RSO and CSO to ensure users are handling and disposing of radioactive and hazardous material appropriately.

Oversees laboratory ergonomics and organization of the lab spaces.

· Collaborates with the Safety and Project Management departments to determine the proper equipment and furniture for purchase and proper placement to ensure safe egress according to ADA requirements. Facilitates and schedule ergonomics evaluation with the Safety Dept. ergonomics staff member.

· Plans methods to maintain or improve operational and financial efficiencies and quality.

· Manages research regulatory and lab safety compliance database and website.

· Schedules training on equipment as needed for the lab personnel and on laboratory safety and regulatory compliance.

· Serves as the University Controlled Substance Manager-Responsible maintaining researcher DEA registrations and oversees the appropriate chain of control regulations set forth by the DEA and that they are met

Responsible for the placement of all compressed gases orders for research and areas of the clinical arm of the university

Research Laboratory Manager Under the Vice President of Research and Biotechnology

Western University of Health Sciences - Pomona, CA January 2016 to December 2017

Research & Biotechnology

Successful management of the maintenance, operations, equipment, and all related infrastructure of all buildings in collaboration with several supporting departments.

· Coordinate the origination and continuance of all required Service Contracts for facilities and equipment.

· Management and implementation of system to ensure sufficient, well-designed swing space for relocation of multiple equipment, communications, furniture and supplies into renovated or new buildings

· Coordinate with multiple departments and contractors (Engineering and Facilities, Information Technologies Services, Biomedical Instrumentation Services, Safety) in timely completion of Facilities and Equipment projects, maintenance, environmental cleanliness and repair.

· Oversee process of maintenance, repair and service agreement costs for research space and devised safety plans for emergency situations. Key on-call responder

· Review, justification, approval, and submission process of equipment and non-Capital purchase orders and vendor services ensuring uniform price structure across the colleges and in alignment with the financial strategies of the

University.

· Develop and implementation of SOP’s

Manager, Research Facilities and Emergency Planning Beckman Research Institute/City of Hope Nat’l. Med Center - Duarte, CA January 2013 to December 2015

Research Operations

Successful management of the maintenance, operations, equipment, cleanliness and all related infrastructure of all buildings (17), collaboration with several supporting departments including: Engineering, Project Management, EVS liaison,

Safety, Purchasing, Information Technology, contractors, subcontractors and vendors.

· Coordinate the origination and continuance of all required Service Contracts for facilities and equipment.

· Management and implementation of system to ensure sufficient, well-designed swing space for relocation of multiple equipment, communications, furniture and supplies into renovated or new buildings

· Coordinate with multiple departments and contractors (Engineering and Facilities, Information Technologies Services, Biomedical Instrumentation Services, Safety) in timely completion of Facilities and Equipment projects, maintenance, environmental cleanliness and repair.

· Oversee process of maintenance, repair and service agreement costs for research space and devised safety plans for emergency situations. Key on-call responder

· Review, justification, approval, and submission process of equipment and non-Capital purchase orders within a 5 million dollar budget ensuring uniform price structure and identifying cost savings

· Management of 1.5 million operational budget

· Supervision of support staff providing various services in support of facilities and principal stakeholders, including hiring, development, process, procedures, and training. Laboratory Manager/ Senior Research Associate / RA III Beckman Research Institute/City of Hope Nat’l. Med Center - Duarte, CA January 2000 to December 2013

Department of Diabetes, Endocrinology, and Metabolism Successful management of departmental laboratory operations, maintenance and equipment functionality in coordination with supporting departments. Quality Control and data management lead; receiving and releasing cGMP goods. Emergency Plan Lead. Responsible for ordering of laboratory supplies and equipment, analysis, interpretation and graphic presentation of experimental data.

· Perform Quality Control (QC) inspection on all items received and released for use in FDA regulated and approved procedure in patients.

· Develop, manage, and administer databases(electronic batch records) and duties essential for receiving and releasing goods used in cGMP environment, and according to Standard Operating Procedures (SOP)

· Inventory maintenance of items received in accordance with FDA regulations

· Report generation of defective items and contacting vendor for resolution and returns.

· Identify and remove items from inventory per FDA/manufacturer recalls.

· Aseptic technique and sterilization process e.g. sterile technique, cell culture

· Lab function, equipment, experiment setup and data interpretation

· Operation of various production equipment such as analytical balances, pH meters, centrifuge, sonicator, CO2 incubator, autoclave, mixers, filtration apparatus, 96-well plate reader, biological safety cabinets, fume hoods, UV and light microscopes

Technical Skills summary

· Perform Quality Control inspection on all items received and released for use in FDA regulated and approved procedure in patients.

· Develop, manage, and administer databases and duties essential for receiving and releasing goods used in cGMP environment, and according to Standard Operating Procedures (SOP).

· Maintain inventory of items received and used.

· Filling out reports of defective items and contacting vendor for resolution and returns.

· Identify and remove items from inventory per FDA/manufacturer recalls.

· Supervise support staff providing various services in support of facilities and Principal Investigators laboratories, including: hiring, development, process and procedures and training.

· Sterile work and sterilization process e.g. sterile technique, cell culture

· Familiar with lab function, equipment, experiment setup and data interpretation

· Use spectrophotometer, plate reader quantitative and qualitative analysis of various assays

· Usage of centrifuges types (bench top clinical low, high-speed and ultra high speed)

· Coordinate the origination and continuance of all required Service Contracts for Facilities and Laboratory equipment, reducing impact on stakeholders work.

· Coordinate with multiple departments and contractors (Engineering and Facilities, Information Technologies Services, Biomedical Instrumentation Services, Safety) in timely completion of Facilities and Equipment projects, maintenance, environmental cleanliness and repair.

· Project management and coordination of major construction projects in collaboration with contractors, architects in providing key detail and decision making to ensure completion is on time, on budget and as requested by client(s)

· Oversee process of maintenance, repair and service agreement costs for research space and devised safety plans for emergency situations. Key on-call responder for all centralized alarmed facilities.

· Manage review, justification, approval, and submission process of Capital equipment (>5K) and non- Capital purchase orders, ensuring uniform price structure and identifying cost savings. Management of facilities budget (1.5M).

· Management and implementation of system to ensure sufficient, well-designed laboratory swing space for relocation of multiple laboratory equipment, communications, furniture and supplies into renovated or new buildings.

Education

Citrus College - Glendora, CA, US

Bachelor's Degree in Business Management

California Creek University - San Francisco, CA, US Pharmacy Technician Program

Loyola Marymount University Extension

Skills

• PC and Mac OS software and hardware experience and knowledge Computer networking, hardware and software install/IT liaison Microsoft Office: Word, Excel, and PowerPoint.

Adobe Acrobat Reader/Writer, Photoshop

Data Analysis: Sigma plot, Prism, Instat, Inplot

• Quantitative Analysis

• CGMP

• Pharmacy technician experience

• Spectrophotometer

• Microbiology

• Laboratory Experience

• Microsoft Excel

• Microsoft Powerpoint

• Microsoft Word

• Facilities Management

• Quality Assurance

• GLP-Certificate of Completion (CEU (20 contact hours) (10+ years)

• FDA Regulations

• Laboratory Management

• Aseptic Technique

Assessments

Basic computer skills — Proficient

August 2022

Performing basic computer operations and troubleshooting common problems Full results: Proficient

Analyzing data — Proficient

August 2022

Interpreting and producing graphs, identifying trends, and drawing justifiable conclusions from data Full results: Proficient

Written communication — Proficient

August 2022

Best practices for writing, including grammar, style, clarity, and brevity Full results: Proficient

Indeed Assessments provides skills tests that are not indicative of a license or certification, or continued development in any professional field.

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