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Quality Document Control

Location:
Monroe, NC
Posted:
May 11, 2020

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Resume:

MICHELE M. THOMPSON 803-***-**** adc554@r.postjobfree.com

Highly motivated and results oriented quality professional with over 10 years of experience in the manufacturing industry. Champion in implementing Quality Management Systems for industries regulated under FDA and FAA regulations and ISO 9001:2008 AS9100 and AS9110 standards. CORE COMPETENCIES

Collins Aerospace (Goodrich Corporation Aftermarket Services) Monroe, NC

(Customer Service site for repair and overhaul of aircraft components) Sr. Quality Control Supervisor 04/01/2017-Present

• Manage quality to ensure products and processes are compliant with internal and regula- tory standards, resulting in zero non-conformances to customers.

• Manage and motivate team of Quality Compliance technical and business support profes- sionals.

• Responsible for the oversight of quality compliance audits with certification as ISO 9001:2008 AS9110 internal auditors.

• Conduct supplier audits as need to endure compliance with regulatory and industry stand- ards.

• Responsible for the integrity of the quality management system to ensure it is maintained during integrations with other companies or the introduction of new products or processes.

• Supervise Document Control Library and Calibration Laboratory and ensuring direct re- ports are meeting pre-defined goals with regular performance meetings and informal dia- logue.

• Maintain compliance for all special process qualified in the facility.

• Manage the annual internal audit program as well as monthly shop audits for compliance, resulting in no major audit findings for the past 2 years.

• Manage supplier quality program to include, external audits, create supplier performance metrics and risk analysis. Issue supplier corrective actions and approve corrective action plans. Maintain the approved supplier list.

• Maintain calibration program with a reduction is findings by 75%.

• Review and regularly revise the Quality Manual and associated flow down procedures to ensure compliance to regulatory, statutory, customer and other industry standards.

• Designated Employer Representative FAA Drug and Alcohol pre-employment and random drug and alcohol testing program for facility to ensure compliance the FAA/DOT regula- tions. Implemented internal procedures to prevent regulatory findings.

• Conduct Root Cause investigation to ensure cause(s) are identified and corrective actions effectively eliminate the root cause.

Lean Six Sigma Methodology

KPI Metrics

Quality Management Systems

Supplier Qualification/Performance

Technical Writing

Process Development/Improvement

ISO 9001:2008 (AS9100/AS9110)

FAA regulatory compliance

Compliance Audits

SAP/ERP Systems

Corrective/Preventive Actions

MICHELE M. THOMPSON 803-***-**** adc554@r.postjobfree.com Nutramax Laboratories. Lancaster, SC (A nutraceutical company focused on Quality and science based development of consumer and veterinary health products) Quality Assurance Lead 10/2012 - 08/2014

• Supervise individuals within the QA department that includes: Document Control, Quality Assurance Generalists and Training, assuring all cGMP requirements and regulations

(including 21 CFR 111, Food Safety Modernization Acts) are met through compliance to government regulations, industry standards and Company specifications policies

• Conduct investigations assessing and closing deviations, determining impact of the is- sues that could affect quality and purity of the product, resulting in a 15% reduction in Customer Complaints for the year

• Perform Internal Audits to ensure compliance to FDA regulations and Standard Operating Procedures and improve quality systems, which resulted in no Major findings by our third party auditor for the first time

• Perform On-site Audits for company’s contract manufacturer to ensure cGMP require- ments and regulations are followed and suggest improvements to processes, which re- sulted in no recorded customer complaints to date

• Work alongside Production Management, and R&D to determine best practic- es/procedures and lead process improvement initiatives, which resulted in 3 process im- provements in the last quarter of 2013 and 2 process improvements the first quarter of 2014

• Manage the Document Control function for South Carolina facility while the department was in a transitional stage, seamlessly transitioned an entire Quality System to the new facility

• Train and develop QA associates to meet company goals and objectives. Coach and provide guidance to Production Supervisors for Investigation, Deviation and CAPA sys- tems

• Acting Quality Manager in the absence of Senior Quality Management Quality Assurance Generalist II 02/2011 - 10/2012

• Conduct, approve and close out investigations, deviations and protocols

• Responsible for performance of attribute sampling for all finished products

• Create, Issue and review protocols for production

• Implement new operating procedures or revise current due to the transition of vet prod- ucts from the Maryland facility to the new South Carolina facility

• Initiate and create training presentations where gaps are found in the Training Program

• Audit production facility for compliance, performance and safety to ensure compliance with cGMP’s

• Track, reviewed, and maintained training documents for all South Carolina employees / departments, prior to creating a Training Department

• Review, create files, and routed for necessary corrections made on batch records, oper- ating procedures or logbooks to ensure compliance

• Maintain all electronic logbooks for deviations, investigations, protocols and change con- trols.

MICHELE M. THOMPSON 803-***-**** adc554@r.postjobfree.com Barrday Corporation Charlotte, NC

(An advance material supplier of composite and protective markets including fiber reinforcements, pre- pregs & laminates, coating adhesives and core materials) Quality Lab Technician 11/2003 - 02/2011

• Perform testing on incoming materials and finished products to ensure all goods meet or exceed both internal and external standards.

• Revise test specifications and workmanship standards to meet customer requirements.

• Approve shipments based on final lab testing results.

• Retrieval and analysis of physical properties to determine trends and improve processes

• Compile inventory reports for production management and scheduling.

• Issue and update Non-Conformance and Corrective Actions to improve performance, processes, and respond to customer feedback.

• Involved with the transfer of Research and Development products to Commercial prod- ucts.

SKILLS/CERTIFICATIONS

• ACE Associate Certification (Relentless Root Cause Analysis)

• FAA Drug and Alcohol Enforcement Representative Certification

• ASQ CQA certification (2012)

• Certified for ISO AS9100 and AS9110 Internal auditor

• Train employees to standards (FDA, FAA, CAAC and ISO/cGMP)

• Microsoft Applications-Word, Excel, Access, Power Point and Outlook, Lotus Notes,

• SAP, Jomar Systems, AS400 systems, Pilgrim, iAudit, Trackwise EDUCATION

02/2018 – present: B.S. Operations and Project Management, Southern New Hampshire University 2005 – 2006 University of Phoenix Business Management & Leadership (12 credit hours) 2002 – 2004: Isothermal Community College, Spindale, NC A.A.S. degree in Business Administration 2004

Graduated with Honors G. P. A. 3.98 (81 credit hours)



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