Quality Assurance

Kristy Frye

**** ********** ***** • Sanford, NC *7330 • 919-***-**** • ************@*******.***

Career Objective

Energetic and conscientious professional combining hands-on experience with proven management, and communication skills. Strong quality, manufacturing, pharmaceutical and biotech background seeking a challenging and rewarding position.

Education

Bachelor of Science • Major Biology • Greensboro College • August 2003

Associates Degree in Applied Science • Central Carolina Community College • May 2002

Associate Degree Bioprocess Manufacturing Technology•Central Carolina Comm College • May 2002

Certificate in Bioprocess Manufacturing Technology • Central Carolina Comm College •May 2002

Work Experience

Caterpillar Sanford, NC

Product Quality Technician (PQT) March 2014- Present

Trouble shooting day to day process problems and forms solutions working with Planners and Engineers. Works closely with Manufacturing Engineers when problems are found to fabricate, assemble and test ideas. Works with Continuous Improvement technicians to get manufacturing personnel the correct tooling required for the job at hand. Works with Planners on process changes and monitors effectiveness. Initiates Quality Alerts, Continuous Product Improvement projects (CPI), analyzes changes to be made, works with Engineers on changes, and performs daily monitoring of machines and yard audits to ensure change is effective. Initiates Quality Alerts in response to dealer and internal feedback to insure defects are mitigated and corrected prior to Pre-Delivery Inspection and dealer delivery. Communicates between assembly technicians and Engineers to resolve issues and implement better practices. Conducts Vital 5 investigations when problems arise to find and correct the cause. Daily monitoring of areas to insure processes are being followed per Standard Work to ensure defect free machines. Liaison to Engineers for pilot builds and day to day operations to ensure Standard Work is being followed or if changes need to be implemented. Acts as a first line of communication between Assemblers, Planners and Section Mangers to solve problems when issues arise.

Skill set: Excellent communication skills and problem solving. Dependable and able to give timely responses and implement solutions.

Product Quality Auditor (PQA) June 2013-March 2014

Inspection of skidsteer machines to ensure Product Quality. Trained and skilled in 5 (out of 6) Quality Bays. Trained in Pre-Delivery Inspector (PDI). Inspection of the machines prior to customer receipt. Ensured machines are built to specification per material call out sheets. Ensured machines are built with correct features and all features of the machine are working correctly and safe. Made the team “floater” in December 2013. Responsible for all Quality Gates when a team member is not present.

Skill set: Excellent time management skill set. Ability to inspect and correct machines as needed to ensure 100% customer satisfaction. Years of leadership experience.

Hatch Beauty Labs Durham, NC

Quality Assurance Manager

(Quality Manufacturing and packaging operations) July 2012-April 2013

Managed Quality Team as well as operations team in all aspects of the facilities operations. Released raw materials for bulk pre weigh operations, performed line clearance for bulk manufacturing as well as packaging of bulk. Final QA approval on all finished product shipments. Produced Certificates of Analysis for finish product release per customer requirements.

Skill set: Excellent managing abilities to manufacture, package, and ship to customer on time. Years of leadership, team building, and problem solving management experience.

Gorbec Pharmaceutical Services Durham, NC

Quality Assurance Manager

(Facilities, manufacturing and packaging operations) June2008-June 2012

Manage QA group in busy contract manufacturing setting in problem solving, scheduling, and team building. Oversee manufacturing and packaging operations to ensure optimal performance, safety, and problem solving solutions. Manage, lead, and coordinate others in performing daily tasks, such as, room clearance and changeovers for manufacturing of batches and packaging operations of the finished product. Lead in inventory management and scheduling with Operations Director. Assists QA and Operations personnel in personnel growth, cross training, and developing leaders. Constant budget review. Final QA approval on all finished product shipments. Author of QA, QC, Facility, Manufacturing, and Packaging SOP’s. Author, reviewer, and approval of Quality Standards; which describe the testing and release process of raw materials, bulk, packaging components, and release of finished product. Work in conjunction with Director of Operations in seeing tasks are performed in compliance to the cGMP’s. Assist in GMP audits performed in house, as well as by the FDA.

Skill set: Excellent managing abilities to manufacture, package, and ship to customer on time. Years of leadership, team building, and problem solving management experience. Most recent FDA audit in December 2010, yielded zero 483 observations.

Biolex Pittsboro, NC

Quality Assurance Specialist June 2007-Dec 2007

Manage and ensure implementation of process audit schedules and risk assessments. Develop and maintain audit tools and conduct technical reviews of audit plans and reports. Evaluate and modify the approach to meet the changing needs of the organization and regulatory environment. Provide team support in the development of process QA strategy and direction.

Skill set: Technical writing, data and trending analysis, plan and deliver presentations,

leadership.

Quality Control Analyst-Microbiology March 2005-June 2007

Conduct routine and non-routine analysis of raw materials, in process, and finished formulations according to standard testing methods. Qualification and validation of in-process and release assays. Perform environmental monitoring of air, surfaces, and personnel. Compile data for department updates or technical reports. Write and update standard testing methods. Participate in assay validation/qualification.

Skill set: Knowledgeable of cGMP’s, good laboratory practices, data trending and analysis,

teamwork.

Manufacturing Associate II August 2004-March 2005

Troubleshoot facility and process equipment. Set-up and adjust equipment as required for proper operation, including disassembly and installation of all equipment and parts required for product runs. Monitors and reviews data to ensure requirements have been met. Work closely with Quality, Development, Facilities, Validation, and other functional area personnel in order to ensure that all manufacturing processes remain in cGMP compliance. Assist in the development and review of SOPs and technical reports pertaining to manufacturing equipment and operations. Maintain records and clean room environment to comply with regulatory requirements, GMPs and SOPs.

Skill set: Problem solving, collaboration, technician, teamwork.

Associate Scientist I September 2003-August 2004

Perform experiments and characterization studies on plant products for growth optimization and commercial proteins. Protein assay and HPLC on samples. Inoculation through recovery process of plant products and proteins. Revise SOP’s and batch records.

Skill set: Investigations, inoculations, research, independent performer.

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