KAREN D. WASHINGTON

acy7ra@r.postjobfree.com

480-***-**** (H)

480-***-**** (C)

Quality Professional with 25 years plus experience in results management maintaining regulatory compliance requirements in various industries from mining to food, pharmaceuticals, nutraceuticals, cosmeceuticals, agriculture / fertilizers & supplements, algae, plastics, and various other products. Provide guidance on continuous improvement plans utilizing automation technology creating greater product consistency, monitoring using lean process controls and data analysis on products, processes, and supplier management to ensure complete company compliance integrity.

•Solid knowledge implementing and maintaining quality certifications with “zero” reportable non-compliances

•Familiarity and experience managing under compliance regulatory bodies such as; FDA,USDA,USP, EU, ISO, NSF, UO, Halal, OSHA, MHSA, and EPA

•Excellent leadership skills in all areas including communication, decision-making, and driving employee training programs

•Work independently or in a team environment collaborating well with Plant and Project Managers, Subject Matter Experts, Engineers, Customers, Suppliers and individuals at all levels

•Detail oriented perfectionist and driven by quality performance

Instructional Designer / Technical Writer with 12 years plus experience in content development for Microsoft software products supplying technical information on new software revisions.

•Create technical documentation and coursework for end-users, IT professionals, system Engineers, and Sales Teams

Experience:

05/2016 – 07/2016 Storz & Bickel America Inc., Oakland, CA (summer position)

Storz & Bickel, is a certified high-quality vaporizer manufacturer. They are a well-established German based company that has distribution world-wide and in the US. Storz Bickel America, Inc. started business in Oakland, California in order to be able to offer American customers direct quick sales and repair services. This facility is currently establishing a Quality System setting up guidance, consistency,

and good manufacturing practices to be compliant with the manufacturing site in Germany which is TUV certified, similar to ISO 9001:2008.

Title: Quality Systems Consultant

•Worked directly with department Subject Matter Experts to understand process functions

•Documented and outlined all department processes and procedures

•Created procedures for invoicing and shipping using Quick Books software systems

•Reviewed and evaluated document accuracy versus processes

•Trained employees while evaluating the accuracy and effectiveness of the document

•Established a CAPA program to enable a vision of overall company performance

•Implemented a statistical quality matrix for each department

12/2015 – Present - Consultant Resource Development LLC. Cashion, AZ

Resource Development LLC., is a company focused on repurposing materials. The company performs reclamation of mine tailings around the world, processing the tailings to remove toxins and heavy metals producing a base fertilizer material for enhancing plant growth in arid areas of the world; focusing predominantly in West Africa currently. In addition to mine site clean-up, Resource Development LLC., also has processes for waste water treatment, algae growing, energy creation, and hydroponics using aquaponics for a self-sustaining processes.

Title: Technical Assistant / Project Coordinator

•Process and document procedures for mine tails for viable fertilizer production

•Coordinate testing for all processed samples

•Record, review, analyze, and report data to Team Members

09/04/2013 – 10/10/2015 Botanicare / American Agritech, Chandler, AZ

Botanicare is a company dedicated to providing the Hydroponics industry experts with superior products.

The company’s products are bottled fertilizers, plant supplements, soil products, and plastic growing trays, some produced on-site but the majority supplied through supply chain vendors.

Title: Quality Assurance Manager

•Created and managed company Quality System

•Worked closely with operators to help determine production flow and procedures to enable the business to run efficiently and profitably

•Implemented a “Chain of Custody” for Supplier Compliance Program for receiving and inspection of raw material inputs

•Managed and reviewed all testing required for company product certifications and customer specifications

•Maintained all product label guarantees monitoring required tests, documenting and tracing result for product compliance

•Researched and implemented where applicable industry requirements to improve company position from quality stance

•Set-up quick visual tests for product verification for receipt of finished goods from suppliers

•Performed quality checks throughout the day on incoming plastic shipments, inspecting product gauge, tooling, and color compliance

• Maintained Customer Complaints scorecard for department quality performance review

•Provided a quality platform for educating and training employees

•Managed continuous improvement program setting new quality incentives quarterly

12/2011– 09/2013 Algae Biosciences Inc., Holbrook, AZ

Algae Biosciences was a start-up manufacturing facility that planned to produce exceptional products from algae. Algae Biosciences products were going to be offered on the International nutraceutical and food additive markets. Private funding for company operations ceased and the production facility closed.

Title: Technical Writer / Quality Manager

•Developed a Quality Management System in compliance with cGMPs under FDA 21CFR Q7A and guidelines

•Created SOPs, process guidelines, and validation protocols for FDA Redbook certification plans

•Designed quality control reviews for monitoring manufacturing processes and product variables to determine product consistency

•Generated reports on processes controls for product efficiency

•Created training documents for all departments

•Performed training on quality sampling aseptic techniques and personal hygiene

•Documented, reviewed, and managed all product, raw materials, and resource test results for product regulatory compliance and integrity

08/2011 – 12/2011 Arizona Natural Resources - Medix Staffing (Temporary)

ANR is a contract manufacturer of cosmetics, cosmeceuticals, skin care, and other bath and body products.

Title: Quality Director

•Managed procedures to ensure process efficiency and product quality

•Maintained a presence on the manufacturing floor, and effectively interfaced with production, scheduling, and distribution departments

•Provided oversight in the development of policies and procedures for continuous process improvements

•Managed cGMP compliance and quality of all manufactured products

•Developed communications, education, and training to instill a compliance initiative in all employees

•Established processes for building quality into products through interactions with R&D, Packaging, Engineering, and Operations

•Reviewed and released approved raw materials, components, and finished products

04/2010 – Present CM Group / Content Masters

Remote location contracting with offices in WA and the UK.

CM Group works closely with internal Microsoft product groups and other leading international software companies to provide advanced software solutions, new products, and innovative training materials which are distributed globally.

Title: Technologist

•Instructor Lead Training (ILT), using Addie Training Model

•Vision Scopes and Functional Specifications development

•SMSG courseware

•Research, collect, and verify subject data

10/2007 – Present Wadeware LLC, Kirkland, WA

Remote location contracting with offices in Kirkland, WA

Wadeware LLC is a contracting company which provides consulting, training, and support services for content development for Microsoft clients Instructor Lead Training and virtual coursework

Title: Instructional Designer / Technical Writer

• Research, collect, and verify subject content and collaborate resources

•Create technical materials, manuals, SOPs, assessment knowledge checks, and documents for training purposes

•PowerPoint graphic editing and design

Course written in collaboration: Microsoft Exchange Server Beta 2010 High Availability updates (Application training) ILT, Microsoft Dynamics Decision Accelerators (Sales training) VILT,

Microsoft Office Communicator 2003/2007 updates (Application training) ILT, Microsoft UC Voice Ignite updates (Application / Technical training), and Microsoft Forefront Security (Sales training)

10/2005 – 05/2006 Sabbatical

•Travel to South and West Africa for 3 months from 10/2005 – 1/2005

•Travel to Europe: Italy, France, and Portugal from 10/2006 - 5/2006

04/2001 – 09/2005 OMYA Arizona, Inc., Superior, AZ

OMYA Arizona Inc. is the largest Calcium Carbonate mining company in the world, which manufactures

Active Pharmaceutical Ingredients (API’s) for finished products in the food and pharmaceutical industries. Calcium Carbonate provides products for uses in a multitude of applications, fortifying products with Calcium. It is also used industrially as a filler in many products; textiles, paints, plastics, and building materials, to name a few.

Title: Quality Manager

•Directed all quality processes for an FDA, cGMP, USP, AIB, HACCP, and NSF regulated facility under 21CFR Q7A requirements for a food and pharmaceutical manufacturing facility

•Managed ISO 9001:2000 standards as the site certified Lead Auditor, which included facilitating internal audits, surveillance audits, and bi-annual management reviews

•Conducted plant tours for regulatory and customer inspections

•Reviewed in-process and finished product testing, monitoring, and tracking product physical properties and conformance using process capability studies

•Ensured timely availability and accuracy of test data for Certificates of Analysis generation

•Reviewed and approved new and revised SOP’s

•Maintained mock re-call and stability testing programs

•Provided quality and safety training for site specific requirements for new employees and vendors

•Supervised vendors maintaining equipment calibrations in QA lab and throughout the plant

•Managed sampling for environmental requirements for the Storm Water Prevention Plan (SWPP), maintaining records and testing for waste water discharge compliance, and Air Quality for ADEQ

•Maintained and resolved customer complaints, corrective and preventive actions

•Prepared budgets, recommended capital expenditures for technology and equipment for continuous improvements

03/1998 – 04/2001 Specialty Minerals Inc. – Lucerne Valley, CA

Specialty Minerals Inc. is a Calcium Carbonate mining company, which produces products for Industrial applications, such as paints, plastics, pool aggregate and roofing tiles, to name a few.

Title: Quality Assurance Manager

•Maintained Quality Management System focused on finished and internal product specifications

•Implemented automated testing technology with process in-line particle size and color analysis supporting product integrity through real-time data analysis

•Reviewed process results and documentation, maintaining all quality control records for site requirements

•Provided support and feedback to plant operations, sales & marketing and customers by generating product performance reports using SPC

•Established continuous improvement projects based on process efficiency

•Managed laboratory and plant equipment and calibrations

0719/96 – 02/1998 Naval Research Laboratory - GEO Centers – Forte Washington, MD Title: Research Chemist

06/1994 – 07/1996 W.R. Grace – Columbia, MD

Title: Research Chemist

Education:

BS Chemistry, University of Maryland

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