Quality Assurance Training

Kenneth Bland

**** ******** ****** • Kansas City, Missouri 64109 • Telephone: 816-***-**** • ***********@*****.***

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Seasoned and resourceful Chemist, offering the ability to conduct accurate and extensive research and perform laboratory analyses and tests; skilled in conducting difficult experimental protocols. A highly functional professional, confident in working independently or in a team and skilled at analyzing, interpreting and communicating data. Demonstrates exceptional analytical, critical thinking, organizational and communication skills. Ability to establish daily priorities, work under pressure, maintain momentum and meet strict deadlines.

• Leadership, Motivation & Teamwork

• Maintains Data Accuracy/Precision

• Analyzing & Troubleshooting Skills

• Standard Operating Procedures SOP • Mycotoxins & Pesticides Laboratories

• Communication/Interpersonal Skills

• Knowledge of all Industry Regulations

• Good Laboratory Practices & Policies • Good Manufacturing Practices

• Quality Assurance and Control

• Project and Process Management

• Skilled in the use of PC Programs

PROFESSIONAL EXPERIENCE

Regulatory Chemist, The United States Food and Drug Administration (FDA), Lenexa, Kansas, 2002-2010

Conducted scientific analyses and tested broad range of food samples to detect pesticides and mycotoxin residue. Maintained HPLC and GC instrumentation while ensuring compliance with strict regulations or procedures. Coordinated meetings with vendors for scheduled maintenance and troubleshooting of any instrumentation and established and maintained professional and productive relationships with vendors.

• Facilitated and conducted effective training programs for new-hire Chemists and instructed staff on the various methodologies and instrumentation techniques necessary for conducting analyses

• Determined concentration of pesticides and mycotoxins residue in food, drugs, and raw material; compiled and evaluated accurate analytical packages of the method used and all results obtained

• Functioned as the lead on the Sample Preparation teams for time-sensitive initiatives for the FDA

• Participated in ISO 17025 Certification and annual recertification and contributed to all in-field inspections; assisted, observed, and evaluated good manufacturing practices/laboratory practices

Diversity Education Cultural Awareness Manager, U.S Food and Drug Administration (FDA), 2006-2010

Provided leadership and guidance to the agency officials on program implementation activities and issued to cultures within the organization. Promoted career development and progression to employees throughout the Food and Drug Administration; interfaced with internal employees to identify their goals.

• Established advisory committees; planned and coordinated workshops and seminars to address concerns and issues, initiated improvement processes, and managed and maintained any budgets

Supervisory Consumer Safety Officer, U.S Food and Drug Administration (FDA), Reston, Virginia, 2006

Composed, reviewed, and issued high-quality Prior Notice center reports and coordinated administrative tasks within the unit. Implemented and strictly enforced policies and procedures and communicated any procedural updates as necessary. Contributed to the annual budget and other resources as related to PNC operations and ensured compliance with financial objectives. Assisted in managerial and all HR activities.

• Fostered a teamwork environment conducted to positive interchange and efficiency/productivity throughout the facility and planned or coordinated daily workflow; adjusted priorities as needed

• Made effective recommendations and decisions on questionable prior notices and ensured any prior notice decisions were made within the mandated timeframes; maintained quality assurance

• Updated the PNC Director/Watch Commanders and/or other higher-level FDA Management in a timely manner – coordinated and directed various high priority issues, activities, and occurrences

• Obtained and implemented new recommendations from PNC employees and created continuous improvement strategies to increase operational effectiveness and daily organizational efficiencies

• Provided positive and corrective feedback to all PNC employees in a constructive manner which promoted a continuation of high-quality work and effective and timely problem/issue resolutions

• Conducted quality control and/or quality assurance review of any PNC work products to ensure all current established procedures, guidelines, or quality levels were consistently met or exceeded

• Reacted, reported, and responded to any PN related computer/IT system outages as necessary to ensure operational impacts were minimized or corrections were made in the least amount of time

Pharmacy Technician, Shawnee Mission Medical Center, Pharmacy (Part-Time), Merriam, KS, 2008-2010

Supported the pharmacist in the filling of prescriptions; located prescriptions, accurately counted pills, measured liquid drugs, recorded all dosages, and compounded various prescription drugs as necessary. Directed the completion of department orientation and pharmacy technician assessments and conducted orientations for pharmacy technician preceptorships. Maintained compliance with all established policies.

Lead Pharmacy Technician, Staff Trainer, Great Plains Compounding Center, Lenexa, Kansas, 2007-2008

Planned and coordinated daily workflow for pharmacy technicians to ensure productivity and efficiency and mandated the training curriculum to all new pharmacy technicians. Ensured all prescriptions were accurately completed and verified by Pharmacists in order to be delivered by the established timeframes.

EDUCATION AND TRAINING

Bachelor of Arts degree with a major in Chemistry – completed General Education and Biology Coursework

University of Missouri, Kansas City – Kansas City, Missouri – Bachelor of Arts degree completed in May 2002

Professional Development Training and Licenses / Certifications / Awards

Performance Award / Recognition from the Food and Drug Administration FDA

Level 1 Certified Analyst and Secret Clearance, Food and Drug Administration

Licensed Pharmacy Technician in the State of Kansas – Completed Training Program

Regulatory Analysis, Total Diet Non-Fat Analysis, Pesticide Analysis, Mycotoxin Analysis Training

Patulin SOP KAN LAB-MYC 44 and Fumonisins AOAC 2001.04 Training Program

Vomitoxin/Don JAOC Volume 79 No. 4, Ochratoxin AOAC 2000.03 and A in Barley (17th ed.) Training

Aflatoxin AOAC 991.31 (17th ed.) and Pharmaceutical Technical Exchange Association Training

Basic Law and Evidence, Regulatory Science, Basic Chemistry, and Verbal Judo Training

Investigative and Interviewing Course and Advanced Chromatography Training Program

GC/MSD Training (Agilent Technology) and DECA Government Training Conference

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