KATHLEEN M. KENNEDY

434-***-**** cell

acpr9t@r.postjobfree.com

QUALIFICATIONS/SKILLS

- Adaptability to changing priorities with the ability to manage multiple projects.

- Cross-functional interaction with all departments in the organization.

- Lead customer complaint investigations to establish root causes and communicate findings and proposed corrective actions to customers

and management.

- Lead investigation teams on incidents and deviations from procedures. Facilitate the implementation of preventive and corrective

actions (CAPA).

- Lead seminars on complex topics for laymen, technicians and scientists.

- Lead customer and regulatory agency on-site visits.

- Comprehend complex government regulations (FDA, ISO, Customer Specific), assess an organization’s system compliance status,

recommend remedial actions and provide follow-up surveillance audit services.

- Lead and direct internal and external Quality Systems audits of written procedures, performance and compliance with regulations.

- Assessment of training needs and the development and implementation of training programs.

- Writing of new and updating existing Standard Operating Procedures, proofreading and editing others’ procedures, administering and

improving procedure system.

- Use of Microsoft Office, including Word, Excel, Access, and PowerPoint. Use of MasterControl document control system.

- Administration of MSDS system. Managed air quality program for OSHA/EPA compliance.

- Technical report writing

PROFESSIONAL EXPERIENCE

NATIONAL TECHNICAL SYSTEMS, Rustburg, VA, January 2012 – Present. Quality Management Representative. Sole QA person for an

EMI/EMC (electronic emissions and susceptibility) testing facility, implementing and monitoring all quality systems. Auditing of testing and

quality system requirements, ensuring testing is performed to customer and military requirements, writing of test reports, trouble shooting,

corrective & preventive action, document control. Includes interaction with customers and facilitating regulating agency inspections.

Requires knowledge of ISO 17025 regulations. Use of MS Office and DAX.

KELLY TEMPORARY SERVICES, Lynchburg, VA, April 2008 – May 2011. Various temporary assignments, including Document Control

Specialist at CB Fleet Pharmaceuticals for 9 months. Duties included approval and review of documents in the document control database,

administration of MSDS system, issuing manufacturing paperwork, filing and other administrative functions. Use of MasterControl

Document Control Software and MS Office. Required knowledge of pharmaceutical and OTC GMPs.

KIK CUSTOM PRODUCTS, Danville, IL, July 2006 – December 2006. QA Manager for a contract aerosol and liquid fill plant. Led a

team of 35 QA personnel, including 3 supervisors. Handled investigation and response to customer complaints. Worked with customers to

ensure manufacturing compliance with their quality requirements. Facilitated FDA and customer audits. Counseled personnel. Involved in

budget decisions for the group. Assisted Director in making decisions regarding a re-organization of the company’s quality systems. Briefed

upper management on quality issues. Required knowledge of OTC and Pharmaceutical GMPs as well as customer requirements. Use of MS

Word, MS Excel and Outlook.

SELF EMPLOYED (Stay at home Mom), July 1998 – July 2006. Raised a family as well as ran a booth at a craft-antique co-op which

required finding of antiques at auctions and other venues and re-selling at the co-op. Also sold on eBay. Worked as part time retail cashier at

the co-op. Volunteered at church and school.

CIBA-GENEVA PHARMACEUTICALS, Broomfield, CO, July 1995 – July 1997. Sales and Marketing Trade Analyst for generic

pharmaceutical manufacturer. Developed database queries, reports and metrics and analyzed sales data for marketing and external sales

teams. Identified trends and recommended courses of action to senior leaders. Served as Marketing liaison for new product introduction

teams. Worked directly with customer support, Marketing Managers and sales staff. Included heavy use of AS400 system as well as

Microsoft Excel, Word and Access.

CIBA-GENEVA PHARMACEUTICALS, Broomfield, CO, August 1994 to July 1995. QA Compliance Coordinator for generic

pharmaceutical manufacturer. Led internal audits of manufacturing processes to ensure compliance with FDA regulations. Facilitated

corrective action teams to identify root causes of incidents (CAPA). Audited internal regulatory submissions for new product approvals.

Managed the customer complaint program. Routinely interfaced with FDA during new product and routine audits. Required knowledge of

pharmaceutical GMPs. Use of MS Word and Excel.

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Kathleen M. Kennedy

PROFESSIONAL EXPERIENCE, continued

STERILIZATION TECHNICAL SERVICES, Rush, NY, April 1992 to August 1994. QA/Regulatory Affairs Supervisor for contract

medical device sterilization and testing facility. Principle interface with FDA and customers during routine and directed audits.

Updated SOP’s, including writing of many new procedures. Led internal audits to ensure USDA, OSHA and EPA compliance.

Performed supplier audits. Worked with customers to ensure compliance with their quality standards Conducted internal seminars on

FDA compliance regulations and product safety initiatives. Knowledge of AAMI guidelines for sterilization and tripartite compatibility

testing for devices. Required knowledge of medical device GMPs. Supervised 3 personnel.

KELLY TEMPORARY SERVICES, Rochester, NY, 1991 to 1992. Clerical functions at many businesses. Included working as a

receptionist at STS (above) where I was hired on permanently as a QA Supervisor.

BIOGENEX LABORATORIES, San Ramon, CA, 1990 to 1991. Technical Sales Representative of In Vitro Diagnostic products. Attended

trade shows, sold tissue staining products to hospital and research laboratories, involved in developing and implementing technical seminars.

Prospecting of new clients, up-sales to existing clients and developing relationship with past clients helped to increase sales by 25% in a few

months.

CHEVRON CHEMICAL CO., Richmond, CA, 1987 to 1990. Research Associate for Agricultural Chemicals Division. Radio-labeled

metabolism studies to ensure compliance with the EPA requirements for pesticides. Use of HPLC and wet bench chemistry.

CORD LABORATORIES (which became Ciba Geneva, above) Broomfield, CO, 1985 to 1987. Quality control chemist for testing of

pharmaceutical raw materials, stability studies and finished products, including chemical and microbiological testing. Use of HPLC, GC, IR,

UV and wet bench chemistry.

MAJOR ACCOMPLISHMENTS

- Lead a new NTS site in the accreditation process which required setting up all quality systems at the facility to conform to ISO 17025

standards and ensuring facility was compliant to the systems. Facilitated audit for accreditation. Obtained accreditation for all 23 tests

on our desired scope within 11 months.

- Leadership role in a reorganization of a quality assurance department at KIK Custom Products resulting in first-ever transition of select

quality duties to the manufacturing group. Made final staff decisions and provided outplacement counseling for affected associates.

Developed and implemented training requirements for new structure. This resulted in our plant being the first plant within the company

to succeed with this new structure. Reduced department hourly headcount from 32 to 12 by realigning functions to the established

manufacturing group resulting in an annual $400K savings.

- Developed a new complaint system for Ciba-Geneva Pharmaceuticals to ensure that customer issues were effectively managed and

handled in a timely manner. Established investigative standards and instituted systems for trending, identification of root causes and

implementation of corrective actions. Cleared backlog of over 200 outstanding complaints in less than three months.

- Led the certification process of a research facility (Sterilization Technical Services) to a fully FDA compliant and registered

manufacturing facility. Defined project scope, directed support systems development, coordinated cross-functional team business and

regulatory issues, and facilitated training development and implementation. Successful FDA certification positioned the company for

new business opportunities.

EDUCATION

MBA, Marketing emphasis, Golden Gate University, San Francisco, CA

Bachelors in Biology, Illinois Wesleyan University, Bloomington, IL

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