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Title Quality Assurance Engineer
Target Location US-MN-Woodbury
Email Available with paid plan
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Pa VangEMAIL AVAILABLEWoodbury, MNHighlights of Qualifications Strong work ethic Candidate's Name
 Self-motivated Team playerEducationBachelor of Science in Biology, Concordia University, Saint Paul May 2017 Associate of Applied Arts, Century College, White Bear Lake May 2011 Associate of Applied Science in Dental Assisting, Century College, White Bear Lake May 2010 Biology CourseworkDeveloped a basic understanding of fundamental microbiological concepts and lab skills including: Characteristics were unique to both eukaryotic and prokaryotic cells. Structural organization and functional roles of cellular components, intercellular communication, and biochemical regulation of cellular activities. How to read and write a scientific article. Laboratory techniques include cell culture, aseptic technique, colony isolation, plating, streaking plating, gram staining, PCR, and Western blotting. How to properly utilize both light and oil immersion microscopy to correctly view microscopic organisms. Studied the human body; cadavers.Work ExperienceQuality Assurance Supervisor, Life Science Logistics, Dallas, TX May 2022-Aug 2024 Third-party logistics (3PL); manage the quality control processes and relationship with logistics providers on warehouse transitions and new construction to improve customer satisfaction from 7 warehouses across the United States. Manage, train, and direct daily operations of a QA team of 6 Coordinators and Specialists, ensuring ISO, cGMP, and CFR compliance and meeting the organization services and quality objectives. 21 CFR 210, 211 and ISO 13485 Medical Devices - Quality Management Systems Led continual development, implementation, and management of QMS system to effectively meet ISO, cGMP, and CFR standards Quality system experience: Deviation, Planned Deviations, CAPA, Change Order, Change Request, Recalls, Reactive Maintenance, Preventive Maintenance, metrics, Vendor Qualification, DEA audits, internal audits, and regulatory inspections Support QA Validation in environment control system: temperature probe placements, data collection, monitoring temperature in a controlled environment, and compiled weekly and month End Temperature reports Collaborate with cross-functional teams in Operation and Facility to improve services and quality review processes Oversee controlled records and assisted in document control Warehouse transition and new construction Review business contracts and proposals of new warehouses (quality contribution). Monitored temperature and humidity in a controlled environment for all warehouses for 18 warehouses across the nation Monitor and prepared Weekly, Monthly, Annual Environmental Control Systems and Temperature reports Review Vendor's qualifications and assist in the Vendor qualification management system Prior yellow belt certification from goleansixsigma Quality Assurance Project Manager, Life Science Logistics, Dallas, TX Jul 2023-Dec 2023 Managed quality events - Deviation, planned deviations, CAPA, Change Order, Change Request, Recalls, Reactive Maintenance QMS metrics, Track and Trend events Trained staffs and collaborate with other departments to complete projects Oversee records and assisted in document control Managed Vendor qualification Stand in for Quality Assurance ManagerQuality Assurance Supervisor, Carie Boyds Prescription Shop, Irving, TX July 2021-May 2022 Managed the Quality aspect of a FDA-registered 503B outsourcing manufacturer facility Experience includes clean room with ISO 5 and ISO 7 Cleanroom standard, research and development laboratory, Quality Control laboratory, Environmental Monitoring, and Aseptic Process Simulation (APS) Verification Managed a Quality Assurance team of 4 to ensure all batch records, master batch records, and R&D Batch records were in compliance and release in a appropriate time frame to meet quota Proficiently leaded and supported Quality Events Management: CAPA, Deviations, Document Control Changes, Change Controls, Investigations, Protocols, Customer Complaints, internal audits, external audits Reported directly to the Quality Director and Stand in for the Quality Director Managed both QA and QC to ensure that operational standards are met. Trained staff. Coordinated work events for staff Write Annual Product Review (APR) and Annual Quality Review (AQR) Root cause analysis, Gap analysis, Average Quantity System (AQS) Quality Assurance Lead, Carie Boyds Prescription Shop, Irving, TX June 2021-2021 Worked at an FDA-registered 503B outsourcing manufacturer facility ISO 5 and ISO 7 Cleanrooms; ISO 14644-1 Cleanroom Standards; 21 CFR 210, 211 Reported directly to the Manager in charge Stand in for the Manager in charge and trained staff Assist in audits: Regulatory, DEA, FDA, Pharmacy, Health Departments Managed employees to ensure that operational standards are met Coordinated CAPA Track and Trend Coordinated Document Control Administrative duties Managed and reviewed Environmental Monitoring Managed Aseptic Process Simulation (APS) Verification Managed Batch Record Dispositions Managed Deviations, Managed Suppliers, investigations, Root cause analysis, Gap analysis Quality Assurance Associate, Carie Boyds Prescription Shop, Irving, TX February 2021-2021 Worked at an FDA-registered 503B outsourcing manufacturer facility ISO 5 and ISO 7 Cleanrooms; ISO 14644-1 Cleanroom Standards; 21 CFR 210, 211 Reported directly to the Manager in charge Stand in for the Manager in charge and trained staff Managed Batch Record Conclusions, Deviations, Suppliers and vendors Managed employees to ensure that operational standards are met CAPA, Track and Trend, Document Control Managed and reviewed Environmental Monitoring Managed Aseptic Process Simulation (APS) Verification Front Desk Officer, Highland Village Smile Studio, Highland Village, TX 2020- 2021 Managed all front desk administrative duties including scheduling Managed schedule for a 4-chair operatory Managed billing, payments, and insurance Insurance verification and processingDental Office Manager, Mint Dentistry, Dallas, TX 2019 Worked in 18 of the Mint Dentistry locations Managed employees to ensure that operational standards are met Managed employees scheduling and paid time off (not including doctors) Ensured staff is on time, in uniform, and prepared for work before patients arrive Conducted morning meetings with a prepared agenda and reviewed daily goals Worked with existing vendor relationships to manage office equipment, utilities, software, technology, and the facility itself and resolved any related problems or needed repairs Managed office supplies and budget Report expenses and End of Month close-out monthly Interview, hire, and oversee the training of new employees Withhold violations of culture, policies, and protocols and provides corrective and/or disciplinary action as needed Administrative duties including checking patients in and out and coordinating payments Treatment planning, billing, insurance and payments with patients Dental Office Manager, Open Cities Health Center, Saint Paul, MN 2018 Reported directly to the Director of Clinic Operations Collaborated with the Dental Director and other Doctors from other departments Managed all activities of the Dental Department Responded efficiently to patients' and doctors' needs and inquiries Resolved patient's issues under company policies and procedures, healthcare regulations, and dental board standards Managed patient scheduling and directed patient traffic flow. Oversee the processing of dental claims Managed specialist referral process and tracking log Recruited and selected office staff to meet operational requirements Managed employee rations. Determined staff schedules and ensure operational standards are met. Additional Work ExperienceLead General, Orthodontic, and Surgical Dental Assistant 2010-2018 English as a Second Language Teacher, Hmong Culture Center, Saint Paul, MN 2007-2009 Volunteer ExperienceTexas Hmong New Year, TX 2019Girl Scouts, Arlington, TX 2019Fitzgerald Elementary, Arlington, TX 2019Asian Adult Day Care, Saint Paul, MN 2018Kent C. Gulden Orthodontic, White Bear Lake, MN 2018 Feed My Starving Children, Eagan, MN 2017Give Kids a Smile, Century College Clinic, White Bear Lake, MN 2008 Union Gospel Mission Dental Clinic, Saint Paul, MN 2008 Continuing EducationEnvironmental Monitoring 2021

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