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Quality Assurance Human Resources

Location:
Brandon, FL
Salary:
50,000
Posted:
September 21, 2023

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Resume:

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LURVIN THERRIEN

CCU Claims Adjuster – Tampa Bay Area FL

Manufacturing Environmental Background

Phone 727-***-**** Email adzu61@r.postjobfree.com

Qualifications Summary

• Bilingual: English/Spanish

• Nearly 10 years of in-depth experience in providing excellent client/customer support, as well as demonstrating analytical and problem-solving strengths.

• 10 years of experience in recruiting with involvement in the hiring process and delegation of work responsibilities among the office personnel (New Hires program).

• Capability to organize, prioritize and work under extreme work pressure, heavy workload, and deadlines.

• Report writing to communicate their findings to senior management, quality auditors typically prepare detailed written reports. ...

• Presenting Alongside written reports, an auditor may also present their ideas and findings at meetings, analytical thinking, attention to detail.

• Process claims rapidly and efficiently.

• Working knowledge of all types of systems such as Accurint, ISO, Microsoft Windows applications, Claim Station, Claim Pro, Lexus Nexis, Referral Hub, Microsoft Outlook, social media and Word Perfect. Proficient in Client Profiles case management system, Factivity (Real-Time Factory Floor Visibility- Supply Chaim Program). QAD-ERP-Enterprise resource planning. Professional Experience

06-2020- 2023 Saint-Gobain; Quality Specialist & Regulatory Affairs Clearwater-Site- Florida USA

• Assist customers and suppliers with complaints and requests regarding regulatory issues.

• Manage reports, certificates, completion of questionnaires for customer and supplier claims in compliance with regulations.

• Internally advises others on process and compliance issues.

• Provide correct and accurate technical review of data or reports, SOP's and ensure compliance with updated peer procedure dates.

• Oversee the planning, coordination, and management of regulatory documentation activities.

• Review, identify and interpret relevant regulatory guidelines and comply with current dates.

• Analyze and evaluate laws and regulations applicable to the process to determine their impact on company activities.

• Compile and oversee the maintenance of regulatory documentation databases or systems,

• Coordinate efforts related to the preparation of regulatory documents or submissions.

• Develop and maintain fluid communication with regulatory agencies regarding pre-filing strategies, compliance testing requirements, potential avenues for regulation or clarification, and follow-up on submissions that are still in progress, and with suppliers of raw materials related to the organization's process.

• Lead and motivate a diverse group of quality employees by encouraging teamwork and continuous improvement to achieve defined goals and objectives.

• Coordinate the calibration program, ensure that calibration activities are completed in accordance with due dates and inventory equipment in accordance with compliance procedures.

• Lead the training program, direct and ensure the team complies with the completion and updating of SOP's.

• Update SOP's, GMP's as needed.

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01-2020- 06/2020 Bausch & Lomb Team Leader

Tampa, Florida USA

• Lead and motivate a diverse group of employees by promoting teamwork and continuous improvement to meet defined goals and objectives.

• Utilizes performance tracking metrics to monitor performance and provides timely feedback to employees on opportunities and recognizes employees for excellence.

• Lead or support CIP initiatives for both technical or non-technical opportunities and works well with cross functional teams.

• Provide mentorship to new team leaders within the department.

• Responsible for multiple departments and coordinates team building activities.

• Ability to work well with key support groups and to provide timely updates to plant management on key initiatives.

• Ensure that employees comply with company policies and procedures.

• Report/Resolve employee related issues with Human Resources.

• Serve as communications liaison between employees and management staff/support groups.

• Coordinate team building activities to integrate employee involvement in projects for both technical and non-technical opportunities.

• Responsible for time and attendance tracking

• Update SOP's, GMP's as needed.

2011 – 2019 Saint-Gobain; Quality Assurance Specialist & Document Control Largo Site-Florida-USA

• Pursues Quality’s organizational objectives by:

• Specialist in training areas

• Preparing and completing action plans.

• Upholding ISO 9001 requirements & ISO 13416

• Identifying and resolving problems using corrective action project management techniques

• Identifying and driving system improvements.

• Maintains quality processes by assisting process owners with writing and updating procedures and process flow diagrams.

• Improves product and service quality by:

• Investigating service and quality issues reported by the field or directly from customers.

• Coordinating improvements in the field and with suppliers.

• Requalifying and evaluating suppliers.

• Review customer surveys for quality systems requirements and statutory & regulatory requirements.

• Develops continuous improvement plans by:

• Conducting gap analyses.

• Identifying best practices.

• Implementing controlled change.

• Monitoring verification procedures.

• Update SOP's, GMP's as needed.

2008- 2011 WEST Pharmaceutical - Quality Assurance Technician Clearwater, Florid USA (Metal Site)

Experience working in a manufacturing environment in compliance with GMP (Good Manufacturing Practice) regulations and knowledge of quality (ISO or ISO 9001) standards and SOP’s 13416.

Inspects and release incoming materials.

Perform inspections of the product, record results, investigate internal and external reports, perform trace-backs and review inspection forms to ensure products meet customer specifications. Perform analytical testing to multiples product IP.

Evaluates, records, and reports on the chemical and physical properties of various substances and materials to determine product release approval status.

Handles retain samples, audit, and release Batch Records, and perform line clearance randomly audits.

Perform daily requested investigations and report it to management.

Send daily emails with any information or issues that need to be reported to management and many other quality responsibilities.

Maintain responsibility of Quality of products and processes to ensure all products delivered to our customer meets or exceed predetermined expectations.

Conduct measurement and analysis of incoming material as per technical specifications to verify quality requirements have been met.

Gather, complete and properly the information of documents needed to meet Quality record Page - 3 - of 3

requirements, test results, reviews, and signatures as a responsible, etc...

Conduct detailed technical quality testing on product prior to shipment to verify proper function as per predetermined standards.

Handle sensitive and confidential information with discretion for clients and the company. Education

2023 – Active Professional Career Institute - 6-20 All Lines license, License Number: W033809 2014 - 2017 UNITEC-BA, Business Administration 3.97 GPA (IP-No graduated yet) 1995 Hight School diploma Graduated.



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