Nivea G. Amaro Cruz
Katy,Tx
Summary
Manufacturing professional with 14+ years of experience, with strong leadership skills and extensive experience in production processes and quality assurance. Known for fostering team collaboration and ensuring seamless operations. Adept at optimizing workflows, improving efficiency, and meeting stringent performance standards. Adaptable and reliable, consistently delivering results in dynamic environments.
Overview
19
19
years of professional experience
Work History
Sr QA Specialist
Willowbend Pharma Select
10.2024 - Current
- Ensured compliance with industry standards and regulations through diligent adherence to established QA procedures and guidelines.
- Assisted in root cause analysis investigations, leading to more efficient problem-solving techniques within the team.
- Served as a subject matter expert within the QA team, providing guidance and mentorship to junior team members and fostering a collaborative work environment.
- Optimized resource allocation for testing activities by managing workload distribution among team members according to project timelines and priorities.
- Educated employees on specific QA standards and confirmed maintenance of standards.
- Developed and implemented procedures to meet product quality standards.
- Created testing protocols to be used across product lines.
- Reviewed production processes and identified potential quality issues.
- Drafted technical documents such as deviation reports, testing protocol and trend analyses.
- Completed supporting documentation for testing procedures, data capture forms, equipment logbooks and inventory forms.
- Conducted data review and followed standard practices to find solutions.
Production Support Compliance Manager
Lonza
03.2023 - 03.2024
- Lead for production, gowning garments and cleaning materials management
- Lead Kanban system for Gowning and cleaning materials
- Lead 6S implementation in Gowning storage area, warehouse and classified areas
- Responsible for laboratory waste management processes from the cleanroom
- Responsible for classified area facility cleaning and oversight of contract cleaning resources
- Ensures thorough and timely generation and completion of CAPA, CCR’s, Risk Assessments and Deviations
- Identity KPI’s and implement a plan to address them
- Maintains owned areas in an inspection ready state and compliance of team in execution of their responsibilities
- Drive continuous improvement activities, strategy development and delivery
- Main point of contact of the department during FDA and internal inspections
- Lead for the implementation of the reusable gowning in the entire facility
Manufacturing Manager
Lonza
03.2022 - 03.2023
- Adherence to safety and cGMP regulations of the team
- Lead USP/DSP activities in the clean room
- Lead of Filling, crimping and labeling activities in the cleanroom
- Planning of daily activities in the clean room and provide first line of problem solving in case of any event
- Identity KPI’s during production and implement a plan to address them
- Ensure critical supplies are in stock and available for production
- Trainer, coach and mentor to the Core levels in the technical aspects of the department
- Escalation to management and interaction with other stakeholders in case of any event (Deviation Investigation Team, QA, MSAT, FE, etc.)
- Contributor or leader on MFG and OE projects to optimize and streamline processes
- Completes and reviews batch records and production documents
- Reviews and approves Batch Records, Change Controls, Deviations and other documentation required for production operations
- Review SOP’s, BR’s and protocols for execution
Senior Manufacturing Supervisor
Matica Biotechnologies
03.2021 - 03.2022
- Writing general SOP’s as part of the facility start up
- Working directly with vendors and suppliers for materials and equipment introduction
- Revision of facilities designs to ensure the right capability of the manufacturing area
- Revision of SOP’s, URS and Protocols
Manufacturing Supervisor
Lonza
04.2020 - 03.2021
- Planning of daily activities in the clean room and providing the first line of problem solving in case of any event
- Ensure critical supplies are in stock and available for production
- Trainer, coach and mentor to the Core levels in the technical aspects of the department
- Escalation to management and interaction with other stakeholders in case of any event (Deviation Investigation Team, QA, MSAT, FE, etc.)
- Contributor or leader on MFG and OE projects to optimize and streamline processes
- Completes and reviews batch records and production documents
- Reviews and approves Batch Records, Change Controls, Deviations and other documentation required for production operations
Core technician IV
Lonza
04.2019 - 09.2020
- Knowledge in Aseptic Techniques
- Preparation of Buffers
- Preparation of component assemblies
- Knowledge in downstream purification process, including different chromatography columns, hallowfiber filtration, and TFF systems
- AKTAPilot and AKTAReady skid
- Equipment and material inventory
- Basic knowledge in SAP
- Leading and planning buffer prep
Core Lead
Lonza
09.2019 - 04.2020
- Planning of daily activities in the clean room and provide first line of problem solving in case of any event
- Knowledge in Aseptic Techniques
- Preparation of Buffers/Media
- Preparation of component assemblies
- Knowledge in downstream purification process, including different chromatography columns, virus removal filtration, and TFF systems
- AKTAPilot and AKTAReady skid
- Basic knowledge in SAP, Trackwise and LIMS
- Leading and planning buffer prep
Core technician II
Lonza
01.2018 - 09.2019
- Preparation of Buffers, laboratory analysis such as pH, conductivity
- Preparation of component assemblies
- Knowledge in the purification of process such as Mustang Q capsule and TFF
- Helping with 6S Implementation project
- Working with the QA Sterility team for rooms Qualifications
- Working with the OE team in order to improve some process
- Implementation of a system in order to have more accountability with controlled documents
- Equipment and material inventory
- Unicorn method training
Core technician III
Lonza
09.2019 - 04.2019
- Knowledge in Aseptic Techniques
- Preparation of Buffers, laboratory analysis such as pH, conductivity
- Preparation of component assemblies
- Knowledge in the purification process, including different chromatography columns, hallowfiber filtration, and TFF systems
- Helping with 6S Implementation project
- Working with the QA Sterility team for rooms Qualifications
- Working with the OE team in order to improve some process
- Implementation of a system in order to have more accountability with controlled documents
- Equipment and material inventory
Manufacturing Associate
AMGEN
01.2006 - 08.2013
- Back up lead
- Preparation of Buffers, laboratory analysis such as pH, conductivity, UV
- Run CIP and SIP of tanks
- Knowledge in the purification of processes such as SP Chromatography, Dowex Chromatography, UF/DF system, spectrophotometer
- Basic Skills For Manufacturing, Millipore (TFF), Rockwell (Automation), Basic SAP and WERUM training
- EDM quality experience, participating in Manufacturing Procedures Redesign Project
- Organize daily tasks following the schedule
- Provide training to new staff
- Revise documents such as SOP’s, Forms and MP’s as part of continuous improvement
- Provide solutions to any situation that occurs in the floor
- Suggest ideas in order to improve process, equipment, safety issues and documentation
- Special Project: preparation, validation and implementation of Electronic Batch Records (SME)
Education
BS - Microbiology
University of Puerto Rico at Humacao
Humacao, PR06.2005
Skills
- Microsoft Office
- SAP
- DM
- Communicative
- Quality and Safety oriented
- Spontaneous and natural leadership attributes
- Decision-making
- Problem solving
- Time management
- SOP writing
- Document reviews
- Training development
- Internal audits
- Compliance documentation
- Training coordination
- Project management
- Risk assessment
- Conducting investigations
Languages
English
Professional Working
Spanish
Native or Bilingual
Timeline
Sr QA Specialist
Willowbend Pharma Select
10.2024 - Current
Production Support Compliance Manager
Lonza
03.2023 - 03.2024
Manufacturing Manager
Lonza
03.2022 - 03.2023
Senior Manufacturing Supervisor
Matica Biotechnologies
03.2021 - 03.2022
Manufacturing Supervisor
Lonza
04.2020 - 03.2021
Core Lead
Lonza
09.2019 - 04.2020
Core technician III
Lonza
09.2019 - 04.2019
Core technician IV
Lonza
04.2019 - 09.2020
Core technician II
Lonza
01.2018 - 09.2019
Manufacturing Associate
AMGEN
01.2006 - 08.2013
BS - Microbiology
University of Puerto Rico at Humacao
Similar Profiles
Roderica SwainRoderica Swain
LVN Charge Nurse at Willowbend Nursing and RehabLVN Charge Nurse at Willowbend Nursing and Rehab
LaCreshia ThomasLaCreshia Thomas
Licensed Practical Nurse at Willowbend RehabilitationLicensed Practical Nurse at Willowbend Rehabilitation
ERIKA L. JAMESERIKA L. JAMES
QRT Prevention Coordinator at WillowBend FarmsQRT Prevention Coordinator at WillowBend Farms
Krystal OlobayoKrystal Olobayo
House Sitter, Baby Sitter at My MotherHouse Sitter, Baby Sitter at My Mother
Edwin AdonisEdwin Adonis
Security Officer at Mercenaries For HireSecurity Officer at Mercenaries For Hire