KATHRYN L. JOHNSON

**** ***** ****** **.

Stokesdale, NC 27357

336-***-**** aceo42@r.postjobfree.com

Vast experience in the pharmaceutical/biotech industry

Core Strengths: professionalism, activator, achiever, deliberative

learner, ideation & discipline

PROFESSIONAL EXPERIENCE

. Authored, developed, established & implemented all facets of ISO 17025

Quality Management System

. Exclusively led I&C division to & through ISO 17025 Accreditation -

Successfully completing accreditation process with no deficiencies

. Develop, organize/direct the execution & performance of all QMS

activities, audits, reviews

. Develop, dictate & coordinate objectives/strategies with directors

ensuring high level objectives are met

. Train associates on the use of QMS procedures, tools and documentation

. Excellent written/verbal communication skills, review skills & ability to

analyze/adjust in a fast pace

. Author/execute Cleaning, Equipment and Software validation protocols,

implementing change controls, and completion of final turn over packages

in a fast paced cGMP environment

. Maintained all facets of a Pharmaceutical/Biotech instrumentation

including all areas of utilities, process controls, labs, waste

treatment, solvent recovery, pilot plant, packaging

. Participated in FDA audits and resolution of CAPA

. Manage non-conformance issues, corrective actions and developed action

plans

. Highly detail oriented, strong interpersonal skills, attentive to company

needs handling sensitive situations in a timely professional manner

. Ensured 21CFR Part 11, 210 & 211 compliance, and ISO 9000/9001

compliance

. Computer skills: Expert in MS Word, proficient in Access, Excel, Power

Point, Adobe, Photoshop, Trackwise, SAP, ISOtrain, Livelink records

management system, Outlook

QUALITY MANAGEMENT SYSTEM DIRECTOR/I&C SERVICES

. Authored, developed, established & implemented all facets of ISO 17025

Quality Management System

. Exclusively led I&C division to & through ISO 17025 Accreditation -

Successfully completing accreditation process with no deficiencies

. Researched, developed, authored & implemented highly detailed Quality

Manual, Quality Procedures, Forms, Audits, SOPs, Schedules

. Direct the execution & performance of all QMS activities, audits, reviews

. Develop, direct & coordinate objectives/strategies with directors

ensuring high level objectives are met

. Monitor training & growth of employees within QMS, formally report

activities to upper management

. Monitor & report on Key Performance Indicators (KPI's), providing

information on a timely basis to top management so that clear future

strategy can be mapped & achieved

. Evaluate trends and develop metric reports, make recommendations and

implement changes

. Liaise with the external assessment body on all matters related to the

external accreditation process

. Coordinate & plan Management Review process, addressing all issues &

ensuring proper follow through on any potential issues (i.e. CAPA,

customer requests, inquiries, training, safety)

. Plan, coordinate & execute Quality Internal Audits as required ensuring

that the performance of the QMS is reviewed at planned intervals assuring

suitability, adequacy & effectiveness & the QMS conforms to planned

arrangements, & is effectively implemented & maintained

. Develop & perform ISO 9001-2000 awareness training & further refresher

training as needed

. Maintain electronic database of work flows & procedures including

develop, maintain/update records, Quality Manual, SOPs, Procedures,

forms, personnel folders, training records etc.

. Maintain records that have been established & provide evidence that QMS

is being followed, & a system is in place for identification, storage,

protection, retrieval, retention & disposition of records

. Ensure top management undertakes periodic but regular assessments of

customer satisfaction & consequent improvements are identified &

implemented

VALIDATION EXPERIENCE

. Author/Execute IOQ protocol & addendums for CIP Circuit and Skids/DCS

System updates

. Author/execute Cleaning/Process Cleaning Validation protocols for new

vessels and associated equipment

. Development of Final/Summary reports depicting Validation results in

concise and clear approach

. Authored IQ and OQ protocols for Blood Plasma Sterile Filling Facility,

including Filling Equipment, Pasteurizers, Loading/Unloading system,

Lyophilizer, and Lyophilizer Loaders, DCS, and SCADA

. Performed setup & execution of SIP & CIP runs on vessels, transfer lines

& panels

. Review and approve Validation protocols developed by peers

. Executed Fermentor IQ protocols, walk down of piping and instrumentation,

redlining drawings

. Author automation protocols, research, collect, and organize data to

develop concise documents

. Developed/executed protocols for HVAC systems

. Authored WFI and HVAC IQ and OQ protocols for American Pharmaceutical

Partners, Inc.

. Updated schematics and Engineering Test Plans and performed software

verification

. Authored TCL batch scripting language for the ABB MOD 300 DCS' RUN and

SETUP OQ for CIP processes

QA RECORDS MANAGEMENT EXPERIENCE

. Processed incoming cGMP records (i.e. Validation, Lab Data, Batch &

Compound Records)

. Control & distribution of Master Level III documents including SOPs,

Batch/Compounding Records, Stability Protocols & Component Specifications

. Served as liaison throughout Internal, Corporate and FDA Audits

. Compiled and issued monthly reports and spreadsheets

OFFICE MANAGER

. Team Building, Policies & Procedures, Contract Negotiations, Accounts

Payable & Receivable, Customer Service

COLLECTIVE INSTRUMENTATION EXPERIENCE

. Performed all areas of maintenance, calibration, loop verification and

repair on process control systems

. Maintained instrumentation/trending on conductivity, temperature,

autoclaves, HVAC, utilities, waste treatment, clean steam, compressed

air, instrument air, cooling towers, nitrogen, WFI, RO skids, CIP/SIP,

solvent recovery, pilot plant, production, packaging control equipment,

lab equipment, level, temperature, pressure, flow, pH, DO, CO2, TOC

. Designed/fabricated electrical and instrumentation differential pressure

prototype system for Utilities HVAC, determined electrical power

distribution and data communications

. Provided technical support to maintenance and operations department

. Performed root cause analysis of problem and resolved them

. Investigated incidents and failure of instrumentation equipment and

recommended changes in equipment to prevent them

. Developed maintenance and operating procedures for various

instrumentation equipments

. Analyzed new installation against schematics, redrew schematics to

properly reflect physical systems

. Maintained Allen Bradley PLCs and SLC 500/150 logic controllers and GE

90/70 and 90/30 computers

. Programmed smart transmitters via handheld monitors, and laptop computers

WORK HISTORY

Cooper Electrical Construction, Greensboro, NC - QMS Director I&C Services

2011-Present

Gannett Fleming Engineering at Grifols, Clayton, NC - Validation Specialist

2011 - 2011

Johnson Plumbing Heating & A/C, Greensboro, NC - Office Manager

2008 - 2011

Wyeth Biotech, Sanford, NC - Senior Validation/Documentation Coordinator

2005 - 2008

INDEPENDENT CONTRACTS (see below) 1998 -

2005

Bristol Myers Products-Morrisville, NC Bristol Myers Squibb-Syracuse, NY

1990 - 1998

. Instrumentation Specialist, Morrisville, NC

1997 - 1998

. Instrumentation Specialist, Syracuse, NY

1990 - 1997

INDEPENDENT CONTRACTS (1998-

2005)

Fluor Corporation/Wyeth Biotech, Sanford, NC - Validation/Document Control

Specialist

Delsite Biotechnologies at Sabila Industriel SA Division of Carrington

Labs Liberia, Guanacaste, Costa Rica

Validation/Engineering Controls Specialist

Val Source Inc. at Diosynth Pharmaceutical, RTP, NC -

Validation/Engineering Specialist

Perigon Engineering at Mills Biopharmaceutical (UroCor), Oklahoma

City,

OK

-

Valid

ation

/Engi

neeri

ng

Speci

alist

Day and Zimmerman International, Inc. at Bayer Pharmaceutical, Clayton, NC

Validation/Engineering/Specialist

Instrument Controls Systems/GE-Winston-Salem, NC - Instrumentation

Specialist

MILITARY EXPERIENCE

Plattsburgh Air Force Base - E-4 Sergeant, honorably discharged

Digital Flight Simulator Specialist, Plattsburgh, NY

EDUCATION

Guilford Technical Community College, Jamestown, NC

2010

Over 50 hours completed in coursework toward Associates in Science, GPA

3.87

CERTIFICATIONS/TRAINING/ASSOCIATIONS

IBTA - International Business Training Association - Certificate of

Excellence 2010 2010

Certified Business Professional in the field of Business Communication

IT Training & Solutions, Inc. - Certified Business Pro. Program - completed

certificate 04/15/10

IT Training & Solutions, Inc. - Problem Solving - completed with

certificate 04/07/10

IT Training & Solutions, Inc. - Business Communication - completed with

certificate 03/18/10

IT Training & Solutions, Inc. - Business Etiquette & Pro. - completed with

certificate 03/10/10

IT Training & Solutions, Inc. - Face-to-Face Communications - completed

with certificate 03/24/10

IT Training & Solutions, Inc. - Customer Service - completed with

certificate 04/01/10

North Carolina Career Readiness Certificate - Gold Level

2009

Six Sigma Red Belt Certification

05/16/06

Responsible Business Communication Certificate of Achievement

02/10/06

Allen Bradley Programmable Controllers Ladder Logic

1997

Safety Rep. Bristol Myers Squibb, Pharmaceutical OSHA regulations

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