Quality Manufacturing

David Ferrell III

**** ******** **** ** **********, GA 30052, 706-***-****, ****************@*****.*** WORK EXPERIENCE

April 2017- October 2017 Shire Covington, GA

Senior Quality Technician VI

Lean Six Sigma/5S and 6S in continuous improvement Responsible for inspection and release of production materials, components, and chemicals to the manufacturing facility.

Inspection and disposition of intermediates and quality oversight of distribution activities, operated stand up forklift.

Review documentation for accuracy and compliance to procedures, and release and reject as appropriate.

Initiation of Corrective and Preventive Action (CAPA) in Trackwise 8 Quality Systems. Support process with timely closure of investigations, corrective actions, and regulatory and non-regulatory observations.

Maintain data integrity and ensure compliance with company SOPs

Understands FDA regulations, GLP, GDP, and GMP pratices.

Navigate successfully in Trackwise 8, and JDE, and Laboratory Information Management System.

Aug 2016-April 2017 Shire Covington, GA

Quality Analyst I

Perform chemical sampling of required chemicals needed for use in manufacturing

Maintain the laboratory and ensure it is maintained in a GMP state

Perform product holds, tagging and un-tagging of non-conforming material in a timely manner.

Monitor product quality through the performance of required visual and functional inspection.

Conduct in analysis of written procedures and submit procedural changes as needed to meet corporate, divisional and regulatory requirements

Created continuous improvements through participation as a team leader and facilitator in the Quality Improvement Program.

Mentor program at Shire

Conduct analysis of written procedures and submit procedural changes as needed

Monitor all aspects of quality control including paperwork, production standards and packaging.

Communicate quality issues or changes to department supervisors, and manufacturing associates to ensure documented resolution of the issue.

Approve product release based on production record review, micro, chemical, and analytical test results.

Sept 2012-August 2016 GlaxoSmithKline Consumer Healthcare Aiken, SC Microbiology Laboratory Analyst/Raw Material Sampler

Environmental monitoring and testing raw materials includes surface Air Sampling (SAS) used in conducting air sampling in different locations inside the plant and monitored product contact surfaces across manufacturing plant.

Conducted monthly Stop for Safety meetings in the microbiology laboratory

Conducted 5S audits and level one inspection of the Quality laboratories making sure areas meeting GMP goals.

Review documentations for quality compliance of testing and releasing of media

Calibrations of laboratory instruments, such as, pH meters, balancers, ahura scanners, and colorimeter.

Reviewed laboratory logbooks and also reviewed LIMS data entries of test results for environmental monitoring and raw material final test results.

Performed equipment qualifications on water baths, refrigerators, incubators, and biofreezers with the use of digital temp tales to make sure the equipment meet their temperature ranges.

Aseptically prepared raw materials and finished product samples for microbial evaluation by using alcohol to wipe down area, gloves, and the use of sterile scoops.

Provided training in environmental monitoring to new associates

Conducted in challenging or analysis of written procedures and SOPs.

Performed growth promotions and sterility checks of media bottles and plates.

Delegated work duties to individual staff members

Identified and evaluated employee training requirements

Conducted Level One audits by supervising a team to complete internal QC audits

Operated sit down forklift

Created safety evaluations of work area and Job Hazard Analysis Jan 2008- Sept 2012 Covidien/Kendall Augusta, GA

Quality Assurance Technician

Performed inspections, checks, tests, and sampling procedures of incoming materials, parts and components used in the manufacture of medical devices, partially assembled or finished medical devices.

Maintain accurate and precise records of all laboratory analysis using appropriate record keeping and documentation processes in file cabinets.

Evaluate problems and made initial recommendations for possible corrective action to supervise.

Perform review of device history records and other documentations for compliance to establish procedure and Good Documentation Practices.

Reworked or rejected subassemblies or finished products as required. Conduct and document process and system audits using written procedures as audit standards.

Placed product on hold as required and upon request and released finished sterilized products in Kronos database by reviewing batch records of materials

Recorded quality test data and observations

Coordinated with forklift drivers to ensure that acceptable shipping standards

Sample retention of final product

Communicated quality information with other shifts and manufacturing departments verbally according to established procedures.

EDUCATION

Georgia Military College-Martinez, GA

Associate Degree Business Applied Science 3.0 GPA

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