Quality Assurance Manager

Cell: 319-***-**** JULIE RADFORD ********@****.***

*** **** **** ******, **** Branch, IA 52358

CAREER SUMMARY

A Senior Quality Assurance professional with a proven track record in compliance auditing,process improvements, and leading change. A solid and diverse background in the manufacture of medical devices, pharmaceuticals, and over-the-counter (OTC)medications, as well as, quality assurance for government services. A proven leader who also possesses Human Resource experience in the areas of recruiting, training and development. Known for having high ethical standards and solid principles that successfully drives change.

PROFESSIONAL EXPERIENCE

LIL’ DRUG STORE PRODUCTS, INC., Cedar Rapids, Iowa 2009-2011

Pharmaceutical,Medical Device, and OTC manufacturing and distribution in 37 countries globally. Diverse product line ranging from FeminineHygiene products, medical devices,over-the-counter medications to automotive accessories, paper goods, and personal necessities.

Quality Assurance Manager

Responsible for Quality Assurance functions supporting three divisionswhich included consumer products, convenience products and international markets. Conducted supplier “current Good Manufacturing Practices” (cGMP) and ISO compliance audits,delivered cGMP training, internally and to supplier contract locations, managed corrective and preventive action process improvement, investigated consumer complaints,managed change control process and conducted internal audits. Developed and delivered training related to policies and procedures for technicians and management. Responsible for development of standard operating procedures, database and documentation control. ISO Registrar, FDA, and DEA point of contact.

• Reduced ISO audit non-conformances from 5majors, 15 non-conformances, and 14 OFI’s in 2009 audit (prior to hire), dramatically down to 0 majors, 1 non-conformance and 2 OFI’s in 2011

• Developed Supplier Quality Audit Program for thirty suppliers, internationally and US based

• Conducted ISO and cGMP audits internationallyand across the US leading to process improvements and better quality from suppliers

• Implemented Pilgrim SmartSolve as the quality assurance software for tracking Consumer Complaints. This increased accuracy, timeliness, and improved reporting tools

• Implemented a statistically valid incoming inspection plan based on ANSI Z1.4

• Assisted suppliers to improve the in-process and finished product inspection methods, allowing for reduced sampling of incoming products, resulting in product acceptance based on Certificates of Compliance (COC)

• Developed and conducted quarterly cGMP training to educate organization on current best practices

• Responsible for Annual Board and Executive Leadership Results Review Presentation

PLASTIC PRODUCTS COMPANY, INC., West Branch, Iowa 2008–2009

Custom injection molding company specializing in appliance parts and assemblies for Whirlpool Amana.

Quality Assurance Manager

Responsible for all aspects of Quality Assurance for a three shift custom injection molding operation. Management of twelve quality control technicians and six team leaders.

• Reduced Defective Parts Per Million (DPPM) from 2900 down to 212 within the first three months

• Reduced scrap costs significantly by conducting daily defect reviewsonsite at Whirlpool Amana

• Redesigned work flow on the production floor that increased through put efficiencies by 25%

SCHENKER LOGISTICS INC., West Branch, Iowa 2006-2008

Third Party Logistics for Procter & Gamble providing servicefrom Iowa to the West Coast.

Training and Development Manager

Responsible for design, development and delivery of training that covered new hires, site safety and cGMP’s for 700 employees. Duties also included Human Resource functions of recruiting, benefits, and OSHA reporting.

• Reduced the number of OSHA claims through Safety Training and Awareness

• Implemented a video communications board in all break rooms and cafeteria

• Trained Quality Assurance team on how to be effective internal auditors which reducedthe number of audit non-conformances found by Procter & Gamble during site audits

ORAL-B LABORATORIES, Iowa City, Iowa 2003-2006

Toothbrush Manufacturing Facility, production and distribution of toothbrushes for the United States and Canada.

Process Leader

Responsible for process improvements through feasibility studies, time trials, Kaizen events, increased productivity, and waste reduction. Managed 80 second shift Teamsters 238 Union employees, scheduled production lines and developed staffing models, compliance, and documentation. Responsible for shift results.

• Streamlined process flow for three custom imprint production lines that resulted in cost savings and process improvements

• Developed a magnetic board with equipment and employee names to allow for visible scheduling of equipment and staff which improved efficiency at start of shift and at shift change

• Completed ISO 9001:2008 Internal Compliance Auditor certification

NCS PEARSON, Iowa City, Iowa 1998-2003

A full service provider of technology, academic, government and professional testing programs around the world.

Process Engineer, NCS Measurement Services 2001-2003

Streamlined work flows and developed process improvements in the print and mailing operations.

• Developed a Supplier Quality Program resulting in a decreased number of suppliers. Developed Supplier Scorecards tracking Right Time, Right Quality, Right Quantity

• Conducted Supplier Compliance Audits and trained purchasing and operations staff on ISO Standards and how to conduct audits

Quality Assurance Specialist, NCS Government Services 1998-2001

Worked with Department of Education to develop and improve government student aide processes and programs.Trained Department of Education Staff in Washington DC on quality metrics. Managed Renewal Application Process. Identified process improvements for streamlining print media and distribution workflows.

PROCTER & GAMBLE MANUFACTURING COMPANY, Iowa City, Iowa 1990-1998

A Fortune 500 multinational corporation that manufactures a wide range of products. Experience in Oral Care and North American Contract Manufacturing Quality Assurance for theHealth and Beauty Care Divisions.

Quality Assurance Associate; NA Beauty Care Contract Manufacturing1996-1998

Responsible for developing an Access database for finished product release process, conducted onsite and internal training for contract manufacturing site technicians and executives and for P&G logistics and quality assurance departments. Conducted key element audits at Contract and P&G manufacturing sites. Handled consumer complaint investigations and resolution for Beauty Care contract manufactured products.

• Developed a repeatable Master Batch Production Record Process for 27 Contract Manufacturing Sites for the North American Beauty Care Contract Manufacturing Division.

• Presented the repeatable Master Batch Production Record Process to P&G corporate executives in Cincinnati, OH. Process was adopted by North American Health Care Contract Manufacturing and reapplied by their Quality Assurance Department

• Developed and deployed training curriculum onTotal Quality Management, Root Cause Analysis, Corrective and Preventive Action, and Statistical Process Control for Contract Manufacturing Sitesand P&G personnel

Supplier Quality Associate, Iowa City Oral Care Division 1990-1996

Responsible for Supplier Quality for the Scope Brand; corrugate, bottles, closures, labels, and shrink bands.Worked closely with Packaging Engineers conducting Design of Experiments and Line Trials. Developed scorecards to track downtime related to supplier packing materials. Conducted Key Element and cGMP audits at supplier sites and P&G manufacturing facilities. Developed In-process and Finished Product inspection sampling plans for Scope production lines

EDUCATION

Bachelor of Arts: Journalism and Mass CommunicationsIowa State University, Ames, Iowa 1988

Coursework included: Business Communications, Public Relations, Speech Communications

PROFESSIONAL TRAINING AND DEVELOPMENT

Certified Global Key Elements Assessment Auditor – Procter & Gamble Manufacturing Company

Organizational Development/Organizational Capability– Procter Gamble Manufacturing Company

PROFESSIONAL CERTIFICATIONS

Certified Lead Auditor ISO 13485:200

Certified Lead Auditor ISO 9001:2008

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