To place my experience and training at the disposal of my employer towards the growth and profitability of the organization.
Overview
20
20
years of professional experience
1
1
Certification
Work History
QA Specialist Vl
LONZA GROUP AG
11.2021 - Current
Supports investigations using problem solving tools as owner or QA approver
Supports execution and closure of corrective actions and change controls as owner or QA approver
Review and QA approve GMP master documents and executed GMP documents from QC, manufacturing, material management, FE, and any other department that supports lot production
Performs in house buffers and media release
Responsible for generation, inspection, and release of labels
Other duties include tracking quality records, QA on the floor execution, and overall cGMP compliance
Perform the Quality Assurance review and approval of GMP documents like master documents, executed documents, and quality systems records: change controls, deviations/ investigations, CAPAs and controlled documents
Coordinate, support, and investigate Corrective and Preventive Actions (CAPAs)
Maintain and manage DMS, SAP, TRACKWISE, MODA EM, and Employee training items until their closure
Assist in Change Control process from initiation, revision of documents and processes up to training and implementation.
Quality Assurance Specialist
QUVA PHARMA, INC.
06.2019 - 11.2021
Work to quality assurance procedures & pharmaceutical compounding specifications as specified in partnership with operation management to eliminate the causes of quality problems
Work to comply with all applicable quality, health, safety, and environmental regulations and other related duties as assigned or indicated by responsibilities
Perform all duties as assigned by management, including but not limited to batch record reviews during
Pre-Checks
Post Compounding Inspection and Document Review
QC samples Collection and Inspection
AQL Check
Final Sign off
Shipping
Perform Environmental Monitoring of Clean Rooms within the ISO 5, ISO 7 & ISO 8, obtaining Viable air samples, Surface samples and Non-Viable air sample
Supports department supervision in Quality Assurance oversight and prioritization of day-to-day responsibilities
Follows all Regulatory, cGMP, GDP, and aseptic techniques as required by the FDA for job function
Demonstrates a high level of discretion in the timely identification, and resolution of events potentially impacting the Quality of products and processes
Provides an established technical expertise for current processes and oversees training of department personnel on new processes
Reviews routine manufacturing, environmental monitoring and quality control data for in-process and finished products
Evaluation of batches / product for compliance with defined specifications
Sampling, Inspection, and Control of commercial product labels
Review and approval of shipping documentation for commercial products
Ensures company compliance to QuvaPharma’s Standard Operating Procedures (SOPs) and Quality Management System (QMS).
Quality Control Lead
IGLOO PRODUCT
08.2016 - 06.2019
Daily verification, documentation, and conformance to specification of all equipment and machines used for production lines
Review and analyze statistical data to ensure continuous process control
Ensure that existing inspection, SPC, and electronic database system are accurate and functioning properly
Identifies and resolves manufacturing problems to deliver production efficiency
Attainment and scrap control results
Implement corrective action through poke-yokes for major quality excursion and other major manufacturing issues
Performing the safely monthly training
Navigate in Oracle and IQIS
Provide improvement to inspection methods and gauging for existing
Monitor operation to ensure that they meet production standards.
Lead Quality Control
ESCO Plastic Company
04.2012 - 07.2016
Read and understand blueprints and specifications
Monitor or observe operations to ensure that they meet production standards
Recommend adjustments to the process or assembly
Inspect, test, or measure materials or products being produced
Measure products with rulers, calipers, gauges, or micrometers
Accept or reject finished items
Remove all products and materials that fail to meet specifications
Discuss inspection results with those responsible for products
Report inspection and test data.
Lead (Coil Department)/ Machine Operator
Goodman Manufacturing Company (Daikin North America)
04.2004 - 04.2012
Provided organization & management for daily operations
Monitored production as well as ensured proper deadlines are being met
Performed audits on daily delivery orders
Monitored and approved materials / sign out sheets
Conducted “hands on” training to ensure employees are working according to OSHA guidelines.
Education
Bachelor of Science - Industrial Engineering
Lamar University
Beaumont, TX
08.2023
Skills
Good Manufacturing Practice Skills Good Documentation Practice Skills Proficient in Microsoft Word, Excel, and Power point presentation Mechanical and Technical Assembly skills, Handling measuring/precision tools, Excellent communication skills in English Work with minimum or no supervision, team membership ability
Applications: Ms-Word, Excel, Power Point, Access, Firefox, Internet Explorer
Certification
LEAN SIX SIGMA YELLOWBELT
LEAN SIX SIGMA GREENBELT
Timeline
QA Specialist Vl
LONZA GROUP AG
11.2021 - Current
Quality Assurance Specialist
QUVA PHARMA, INC.
06.2019 - 11.2021
Quality Control Lead
IGLOO PRODUCT
08.2016 - 06.2019
Lead Quality Control
ESCO Plastic Company
04.2012 - 07.2016
Lead (Coil Department)/ Machine Operator
Goodman Manufacturing Company (Daikin North America)
Responsible person on the construction site at Aquist, Switzerland (Lonza AG, Visp)Responsible person on the construction site at Aquist, Switzerland (Lonza AG, Visp)