Christina Briggs
Marriott-Slaterville,UT
Summary
Experience in creating, implementing and maintaining a Quality Management System in compliance with ISO 9001, ISO 22000 and ISO 13485. Experience in conducting test to determine quality of raw materials, intermediate and finished products. Quality control professional experienced in developing organization's quality strategy, procedures, and processes. Monitor quality performance from supply chain and throughout product development life cycle. Develop and sustain Quality Management System in accordance with ISO and other applicable standards and business requirements. Manage quality audit program to identify and resolve non-conformities and embed culture of continuous improvement. Precise Quality Assurance Manager proficient in all QA operations, policies and procedures. Experience hiring and developing individual team members. Committed to thoroughly assessing product quality and manufacturing processes to achieve excellent results and customer satisfaction.
Overview
28
28
years of professional experience
Work History
Director of Quality
Allergy Research Group
01.2022 - 05.2022
- Product Development, Research and Development (R&D), Purchasing, Label Control, Compliance with International Regulations, NSF (National Sanitation Foundation) Compliance, Maintenance and Updates to Quality Management System (QMS), Handling Complaints, Corrective and Preventive Actions (CAPAs), Remote Management of 4 Locations, Coordination with Contract Manufacturers, Collaboration with Distributors, Vendor Support, Marketing Support, Conducting Mock Recalls, Addressing Deviations, Managing Master Formulas, Providing Technical Support, Oversight of Raw Materials, Employee Training
- Applied coaching techniques and tools to support managers and team members in improving performance
- Recorded, analyzed, and distributed statistical information
- Established and tracked quality department goals and objectives
- Established and oversaw company-wide Quality Management System (QMS), maintaining compliance with ISO 22000 and enhancing internal outcomes
- Inspected products and worker progress throughout production
- Determined quality department standards, practices, and procedures
- Oversaw QA operational activities such as sampling, inspection, and line monitoring, verifying compliance with prescribed fault rates and tolerance goals
Quality Manager
UST Corp
12.2019 - 12.2021
- Document and Record Control, Implementation and Maintenance of Quality Management system, Preparation of Quality Management System for compliance with ISO 17025 Certification, Post-production record reviews, Assigning appropriate testing, review and approve/rejection of test results, Tracking and Analysis of test results, Review and Approval of Formula approval and required testing, Raw Material Specifications to meet final specifications of contract material, Master Manufacturing Records creation and reviews, Collection and retention of documentation requirements for Raw Materials and Finished goods in compliance with FDA requirements, Approval of Final COA’s within specifications, Assist CEO with End of Month targets, NCR’s/MRB reviews and dispositions, Lab coordination, Creation of Training Program, Quizzes and implementation
- Inspected inbound and outbound products for compliance with established industry standards, company policies, and procedures
- Evaluated quality problems and performed assessments to identify and resolve issues
- Managed and archived quality documentation and participated in internal and external quality audits
- Devised specifications for processes
- Developed and deployed production control plans and created work instructions and procedures
- Increased customer satisfaction through adherence to quality standards and customer requirements
- Provided observations, took measurements, and performed tests at various stages according to the quality plan.
- Improved quality processes for increased efficiency and effectiveness
- Identified and communicated customer needs to supply chain capacity and quality teams.
- Defined clear targets and objectives and communicated to other team members
- Used industry expertise, customer service skills, and analytical nature to resolve customer concerns and promote loyalty
- Established team priorities, maintained schedules, and monitored performance.
- Improved staffing during busy periods by creating employee schedules and monitoring call-outs
- Evaluated employee performance and conveyed constructive feedback to improve skills
- Established performance goals for employees and provided feedback on methods for reaching those milestones
Quality Assurance Manager
Pharmachem Laboratories
10.2015 - 12.2019
- Assist in Maintaining Quality Management System, Managing Master Production files, Assisting in the creation of Master Production files, Document and Record Control, Maintaining Non-Conformances, Deviations, CAPA’s, along with investigations, Monitoring Preventive Maintenance, Internal Audits, Label Control, Mock Recalls, Pre and Post Auditing of Production packets, Assist in creation of Raw Material specification, Maintaining and creation of COA’s for Finished Goods, Ensuring correct testing for Finished Goods and raw Materials, Creation of customer-specific statements vs Raw Material (Allergen Statements, Gluten-free, Non-GMO, etc.), Maintaining and submission of Materials required for Kosher and Organic Certifications
- Recorded, analyzed, and distributed statistical information
- Reported production malfunctions to managers and production supervisors
- Inspected products and worker progress throughout production
- Assessed product quality by monitoring quality assurance metrics, reports and dashboards
- Created and maintained quality management systems to align with industry standards
- Conducted process and system audits to identify areas of improvement and enforce compliance with industry standards
- Investigated customer complaints and performed corrective actions to resolve quality issues
- Developed and implemented comprehensive quality assurance plans to monitor product quality and adherence to regulatory standards
- Developed quality planning for multiple new product launches by verifying customer requirements and implementing in design and production
- Established and tracked quality department goals and objectives
- Applied coaching techniques and tools to support managers and team members in improving performance
Quality Assurance Manager
JTECH Medical
11.2004 - 08.2015
- Implementation and Certification of Quality Management System in compliance with ISO 13485:2003 & ISO 9001:2008, Analyze Data through Returns, Complaints, NCR’s, CAPA’s resulting from 7% failure in 2007 to 1% through 2015, Document Control, Record Control, QMS Management Reviews, Monitoring Internal Audit Team of Quality System Processes, Supplier Evaluations, Incoming Inspections (Raw Materials), Production and Outgoing Inspection (Finished Goods), Coordination of annual Calibrations for Internal Weights and Tools, Monitoring of Process Validations of Finished Goods and Software, Review of Label Specifications, Device Master Records (Quality Plans), Rework Instructions, Assembly and Testing Procedures, Ensuring QMS was being followed as defined
- Monitored staff organization and suggested improvements to daily functionality
- Recorded, analyzed, and distributed statistical information
- Assured consistent quality of production by implementing and enforcing automated practice systems
- Implemented new quality assurance and customer service standards
- Reported production malfunctions to managers and production supervisors
- Inspected products and worker progress throughout production
- Assessed product quality by monitoring quality assurance metrics, reports and dashboards
- Created and maintained quality management systems to align with industry standards
- Conducted process and system audits to identify areas of improvement and enforce compliance with industry standards
- Investigated customer complaints and performed corrective actions to resolve quality issues
- Developed and implemented comprehensive quality assurance plans to monitor product quality and adherence to regulatory standards
- Collaborated with cross-functional teams to develop and implement process and system improvements
- Tracked quality issues with external customers, suppliers, and internal plant operations
- Developed quality planning for multiple new product launches by verifying customer requirements and implementing in design and production
- Established and tracked quality department goals and objectives
- Applied coaching techniques and tools to support managers and team members in improving performance
- Determined quality department standards, practices, and procedures
- Specified quality requirements of raw materials with suppliers
- Collaborated with audit clients and action owners to apply root cause analysis guidance and establish effective corrective action plans
Claims Billing
Express Personnel Services
02.2004 - 11.2004
- Temporary work with CHC, Responsible for Insurance verification, Responsible for accurate billing of office claims
Customer Service/Documentation Supervisor
Praxair
12.1999 - 08.2003
- Responsible for supervision of all Customer Service and Documentation Representatives, Quality checks of all new patient setups, i.e
- Bili-Lights, Oxygen, Ventilators, Apnea Monitors, Oximeters, Quality checks of all DMERC CMNs, Quality checks of all generic prescriptions, Assisting A/R Representatives with billing errors, Medicare Reviews and Authorizations, Assisting patients with billing issues, Assisting patients in all possible ways to make sure they are in good care and satisfied with experience, Responsible for daily validation and daily order selection reports, Assisting with authorization Renewal Reports, Working with our source DME companies when additional or non-stock equipment is needed
Claims Processing Manager
Futurevision Technologies
08.1994 - 12.1999
- Responsible for 40 data entry and 6 imaging personnel, Quality check of keyed claims, Responsible for computing data and downloading to various contracted Insurance Companies, Bonus Charts
Education
Some College (No Degree) - General Office Services
Salt Lake Community College
Salt Lake City, UTSkills
- Operational Excellence
- Documentation Control
- Quality Management Systems
- ISO standards knowledge
- Employee Training
- Problem-solving aptitude
- Employee Supervision
- Effective Communication
- Strong Work Ethic
- Critical Thinking
- Attention to Detail
- Analytical Thinking
- Organizational Skills
- Policy Reinforcement
- Interpersonal Communication
Timeline
Director of Quality
Allergy Research Group
01.2022 - 05.2022
Quality Manager
UST Corp
12.2019 - 12.2021
Quality Assurance Manager
Pharmachem Laboratories
10.2015 - 12.2019
Quality Assurance Manager
JTECH Medical
11.2004 - 08.2015
Claims Billing
Express Personnel Services
02.2004 - 11.2004
Customer Service/Documentation Supervisor
Praxair
12.1999 - 08.2003
Claims Processing Manager
Futurevision Technologies
08.1994 - 12.1999
Some College (No Degree) - General Office Services
Salt Lake Community College
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