KAYLE A. COOPER

***** ***** **** **

Knoxville, MD 21758

937-***-****

EDUCATION: University of Toledo, Toledo, Ohio

Bachelor of Science, June 1990

Major: Biology

Minor: Chemistry

EXPERIENCE:

Keurig Dr Pepper October 2023 to present

QA technician, Aspers, PA

DAP Products (RPM International) April 2018 to October 2023

QC Manager, Dayton, OH

Manufacturing facility of caulks, sealants, Rustoleum paints. Manage daily activities of QC Lab and 5 technicians. Responsible for product formulations and batch adjustments/OOS. Maintain site QMS. Conduct self assessments. Generate Right the First Time metrics and monthly reports. Maintain formula revisions and changes. Set up of new test methods, SOPs and equipment. SAP, Product Vision, WIN SPC and consumer complaints/CAPAs. QA lead on plant R&D trials. Six Sigma Green Belt trained

Spectrum Brands—Global Auto Care 2017 to 2018

Supplier/QA/QC Manager, Dayton, OH

Startup manufacturing facility of consumer products. Develop and maintain Supplier Quality Management Program—risk assessments, audits, scorecards. Manage material quality issues, investigations and CAPAs. Establish incoming material receiving program—SOPs, train organization, mitigate incoming material quality risks. Manage QC lab of 5 technicians. SOPs/training of testing methods. Batch release, equipment calibrations, internal audits, specification management

US Nonwovens—Household Cleaning Products 2016 to 2017

QA Manager, Ludlow, KY

Manufacturing facility of cleaning products. Ensure adherence to SOPs, policies. Responsible for plant and external GMP audits, CAPAs, OOSs, SOPs. Batch and Finished product release. Manage daily activities of 2 labs and 8 QA lab technicians

Procter & Gamble—Family Care 2013 to 2016

R&D Site QA Manager, Cincinnati, OH

Lead Quality Systems at R&D facility and Pilot Manufacturing plant for paper products. QA leader on

Site management team. Ensure site maintains QA systems/SOP compliance to internal and external

Requirements. Lead Quality Incident/Deviation investigations and CAPA development.

Management of CAPAs via electronic Trackwise system. Maintain Site scorecard/quality metrics.

Lead sector company Quality Systems for continuous improvement, production, labs and materials.

Site GMP auditor. Management of 10 QA technicians

Procter & Gamble—Health Care QA 2010 to 2013

Starting Materials Auditor, Mason, OH

Lead Starting Materials program to maintain compliance quality of active Pharma and excipient

Suppliers. Management of 4 auditors and engagement with global auditors. Audit of suppliers

and P&G sites via 21 CFR and 13475. Lead and participate in investigations regarding product

quality and system issues. Assist with plant process/quality improvements. Evaluate and approve

Change management, risk assessments, ASLs. Lead stability and validation programs

Procter & Gamble—Health Care QA 2008-2010

R&D External Supply Organization QA, Mason, OH

Supported and Leadership to Drug,Cosmetic and Medical Devices Contract Manufacturers, Ensure QA/GMP 21 CFR/FDA/External requirements are met. Training of contractors on P&G systems. Lead investigations regarding product quality and system issues, management of CAPA system. Approval of written procedures, batch records, specifications, deviations, validations. Write/revise SOPs

Procter & Gamble—Health Care QA 2005 to 2008

R&D Oral Care QA Manager, Mason, OH

Provide leadership on existing and new products (OTC Drug and Cosmetics, Medical devices) to

ensure QA/21 CFR GMP requirements are established and technical readiness is met by desired launch

timing. Fully participate on initiative teams and work closely with capability organizations

to ensure clinical & consumer studies meet all applicable regulations. Contribute strongly to the

development of robust material/product/package qualification programs, including stability

and validation strategies. Provide QA insight and approval to investigations regarding product

quality and system issues. Manage CAPAs for contract manufacturers. Help develop and

streamline quality systems and SOPs to continue to develop efficiency within QA systems.

Provide QA support to P&G owner manufacturing sites.

Procter & Gamble—Health Care QA 2002 to 2005

Pet Health and Nutrition (Iams), Lewisburg, OH

Quality Assurance Technical Leader

Supervision of 8 QA employees and lab testing/functions. Maintain food safety, regulatory

and company quality standards. Ensure adherence to proper sanitation/GMP compliance.

Manage formula/product changes. Evaluate customer complaints. Assist with plant process/

Quality improvements. Environmental monitoring and pest control

Mike-sell’s Potato Chip Company, Dayton, OH 2000 to 2002

Quality Assurance Manager

Responsible for maintain food safety, company quality standards and external FDA compliance.

Supervise lab QA technician. Maintain HACCPprogram, AIB and FDA standards, pest control, complaints/CAPAs

Community Tissue Services, Dayton, OH 1999 to 2000

Quality Control Technician

Reviewed donor chart and processing documentation prior to release of tissue

Processing Technician

Processed skin and bone for all grafts according to AATB standards

Dole Fresh Vegetables, Springfield, OH 1998 to 1999

QA Supervisor

Facility startup of QA Lab (equipment, SOPs, training, QA manual). Plant GMP/HACCP

Development and training. Supervise 5 lab technicians. Maintain and review on-line QA

Testing. Manage formula/product changes. SPC programming/implementation/training/

file maintenance. Environmental monitoring (ATP swabbing). Maintain HACCP program and audits. Maintain Sanitation schedule

Campbell Soup Company, Napoleon, OH 1994 to 1998

Chemist/QA Supervisor—Chemical Residue Analytical Lab

Supervise daily lab operation and activities of 5 technicians, maintain 5 HP5890/6890

GCs (FID, ECD, FPD, NPD), 2 LCs and GC/MS. Interpret results of pesticide residue analyses

and troubleshoot analytical problems. Modified and implemented lab SOPs. Generate

reports and SQC. Ensure compliance to FDA standards

B.E.C. Laboratories, Toledo, OH 1990 to 1994

Chemist—Microbiology Department

Medical device endotoxin testing by GC (FID) and clean room

Environmental Chemist

Metals testing by AA and ICP

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