Experience

HPP: Houston Plastic Products

• United States
• Plastics Manufacturing
• 1 - 100 Employee

• Quality Assurance Manager

  • Jul 2022 - 1 year 6 months

  Houston, Texas, United States - Maintain and improve ISO 9001 QMS processes. - Promote quality achievement and performance improvement across the organization. - Monitor and advises on how the system is performing, including collecting and analyzing performance data regarding company performance against set measures. - Ensure procedures are properly understood, carried out and evaluated. - Coordinator with customer and company customer service team for all customer complaints.



Seatex

• United States
• Chemical Manufacturing
• 1 - 100 Employee

• FDA Coordinator

  • Sep 2020 - Jul 2022

  445 Highway 36 N, Rosenberg,Tx 77471 • Maintain Internal Audit Schedule. • Maintain FDA written programs as well as ensuring all applicable employees working with FDA products have been effectively trained and documented for both training and evaluations. • Investigate and resolve Customer Complaints. • Audit 3rd party site, monthly. • Manage Approved Supplier Audits and engage with vendors. • Oversee compliance and ensure that all FDA regulations and policies are followed during blending and packaging operations… Show more • Maintain Internal Audit Schedule. • Maintain FDA written programs as well as ensuring all applicable employees working with FDA products have been effectively trained and documented for both training and evaluations. • Investigate and resolve Customer Complaints. • Audit 3rd party site, monthly. • Manage Approved Supplier Audits and engage with vendors. • Oversee compliance and ensure that all FDA regulations and policies are followed during blending and packaging operations to ensure strict adherence to all FDA requirements. • Perform Laboratory and Manufacturing Internal Audits and In-process inspections. • Investigate CAPAs using root cause analysis. • Complete Annual Product Reviews (APR) utilizing Datacor (Chempax) ERP. • File required annual documentation through FDA CDER Direct Electronic Submissions Portal for all applicable Seatex product labels. • Participate and assist with regulatory inspections (FDA). • Develop Corrective Actions, Root Cause Analysis, and official FDA responses. • Maintain Master Batch Records. (Review data and perform statistical analysis) • Author, review, implement and evaluate SOPs for all applicable FDA processes throughout the facility Show less



Daniel Brown State Farm Insurance

• Office Manager

  • Apr 2016 - Dec 2019

  • Managed schedules, organized office functions, and supervised daily operations of office. • Hired and trained new employees, providing initial support. • Developed new office procedural guidelines, improving efficiencies by26%. • Resolved customer complaints and negotiate solutions. • Ensured accuracy for daily deposits and other banking interactions.



Seatex

• United States
• Chemical Manufacturing
• 1 - 100 Employee

• Quality Assurance Specialist

  • Apr 2013 - Jun 2015

  Rosenberg, Texas • Conducted quality assurance audits • Consulted with management to resolve quality and production problems. • Effectively communicated between upper management, production staff and customers/clients. • Consulted with plant management and personnel on better operational procedures to improve overall efficiency and product yields. • Discussed plant evaluation with plant manager, made appropriate recommendations and set timetable for improvement and corrections. • Wrote, reviewed,… Show more • Conducted quality assurance audits • Consulted with management to resolve quality and production problems. • Effectively communicated between upper management, production staff and customers/clients. • Consulted with plant management and personnel on better operational procedures to improve overall efficiency and product yields. • Discussed plant evaluation with plant manager, made appropriate recommendations and set timetable for improvement and corrections. • Wrote, reviewed, and implemented SOPs (Standard Operating Procedures) and/or QMS documentation to ensure regulatory compliance. • Documented, filed, and controlled all reports as required. • Performed trainings and prepared new employees for their positions. • Led ISO Audits, investigations and follow ups • Performed internal audits and reported findings which showed nonconformity in the Quality Management System. • Performed investigations and applied root cause analysis. Show less



PRACS Institute

• United States
• Research Services
• 1 - 100 Employee

• Laboratory Supervisor/Principal Investigator

  • Jun 2009 - Oct 2012

  • Assigned individuals to perform specific study activities, assigned project leaders, and coordinated all study activities. • Conducted investigations related to study activities when called for by SOPs or as assigned by upper management. • Accountable for the accuracy and quality of the data generated by members of the team. • Identified and defined problems in a timely manner and evaluated the potential impact. • Reported status of work, problems, and their resolution to the… Show more • Assigned individuals to perform specific study activities, assigned project leaders, and coordinated all study activities. • Conducted investigations related to study activities when called for by SOPs or as assigned by upper management. • Accountable for the accuracy and quality of the data generated by members of the team. • Identified and defined problems in a timely manner and evaluated the potential impact. • Reported status of work, problems, and their resolution to the Laboratory Director. • Ensured the appropriate flow and integrity of work in progress. • Provided progress reports and updates to the client. • Supervised the laboratory work and guided staff in meeting SOP requirements. • Verified all documentation followed company policies and regulatory requirements (SOP, GLP). • Participated and assisted with regulatory inspections (FDA) and sponsor visits as needed.

• Project Associate/Quality Control Documentation Specialist

  • Dec 1999 - Jun 2009

  • Assured the data and the documentation for the assigned projects were compiled and checked for accuracy. • Ensured data met SOP control limits. • Ensured quality and integrity of data. • Ensured the completeness of documentation pertaining to a study. • Wrote reports for the sample analysis and validations.