WAYNE KOEHLER

Minneapolis, MN *****

952-***-****

ac8pks@r.postjobfree.com

http://www.linkedin.com/in/wayne-koehler-73112528

Objective: Quality Professional seeking manufacturer to improve methods, train and hire personnel and create opportunities for growth with existing and new customers

AREAS OF EXPERTISE

Quality Assurance

FDA Regulations

Leadership/Training

ISO Certification 9001

Prop 65 chemicals

Process Validation

Contract Manufacturing

Vendor Certification

Internal and External Audits

Technical Background

.PROFESSIONAL EXPERIENCE

Validation

Takeda, Brooklyn Park, MN 4/2019-present

Temporary position

Hired to help validate the CIP and SIP process for a newly installed drug line

Change Control Management using LEADS

Production Superintendent

Conklin Industries, Shakopee, MN

Chemical Manufacturer 4/2018 - 6/2018

•Hired to improve existing manufacturing processes

•Hire and train new personnel to support expansion

•Left as job description did not match the actual jobs I performed

Supervisor/Chemist

Aveda, Blaine, MN

Cosmetic Manufacturer 11/2014 –4/2018

•Hired to supervise the second shift 1 assoc. chemist, 1 lab tech, 1 sampler

•Use SAP program to enter data and release mass, post-fill and raw materials

•Direct the daily tasks of three QA personnel prioritizing their tasks

•Perform Testing by UPLC of quasi-drug in hair color for Japan and domestic market and preservatives used in cosmetics

•Used SAP to enter SCAR for suppliers

•Tested incoming third party OTC products for potency, appearance,etc.

Quality Manager

Illume Candles, Bloomington, MN

Contract Manufacturer – Candles 10/2013 – 09/2014

•Hired to improve oversea (China, India) and domestic component quality.

•Standardizing work instructions and reviewing and improving quality management system.

•Supervised three analysts on two shifts

•Created Cost of Quality metrics to include scrap costs.

•Released product and reviewed and signed COA’s

Quality Assurance Analyst (temporary)

Hawkins Inc., Minneapolis, MN

Contract Manufacturer - Chemicals 07/2011-02/2012

• Prepared for customer audit, updated SOP’s.

•Verified clean rooms class 10,000 and 100,000 were ready for release.

•Monitored HACCP program.

•Released product and reviewed and signed COA’s

Quality Assurance Supervisor

Robinson Pharma, Santa Ana, CA

Contract Manufacturer – Vitamins 05/2009-03/2010

•Used CAPA and Pareto to reduce foreign material contamination from 23 % to less than 1 % in Vit E softgels for Walmart

•Supervised 5 QA Inspectors in production, 1 QA in Packaging,2 QA in the label room on second shift and 4 QA Inspectors and 1 Lead QA on third shift.

•Wrote new SOP's for the Label room, Encapsulation, and Packaging and cleaning validation to bring them into compliance for new FDA CFR cGMP in 2010.

•Reviewed and signed all Master Formulas to insure the ingredients and amounts met the customers label claim.

Quality Assurance, Quality Control Manager

Vita Tech International, Tustin, CA

Contract Manufacturer – Nutritional Supplements 02/2006- 04/2009

•Supervised 14 personnel including: 6 QA Inspectors, 2 QC Chemists, 1 QA Analyst, 2 QA Specialists and 3 Administrative Assistants

•Initial staff was 2 Inspectors, 1 Chemist, 1 Analyst and 1 Admin Assistant

•Increased data collection and dissemination by having all test data, entered into the QMS system I created (physical, chemical and micro).

•Updated existing SOP's to meet new FDA CFR cGMP standards

•Brought the existing Stability program into compliance.

•Lead blend and cleaning validation of new product for overseas customer.

•Hired and trained new personnel to support the company adding a second shift.

•Designed the new Lab for ICP/MS and Atomic Absorption (AA) Flame/Graphite Furnace and sample preparation.

•Prepared for five Audits (certified by NDA under new FDA CFR cGMP rules in 2007)

•Released product and reviewed and signed COA’s

Quality Compliance Specialist (temporary)

Bio-Rad Irvine, CA

Medical kit manufacturer 10/2005 - 02/2006

•Inspect product being filled in packaging dept. for quality, documenting each lot for any variances

Quality Assurance / Quality Control Manager

Levlad Inc., Chatsworth, CA

Contract Manufacturer – Cosmetics 4/2001-9/2005

•Hired to build and train the Quality unit from one QC tech to the staff of one QC Chemist, two QC techs, one QA document control clerk, two shipping QA clerks, five QA line inspectors, three QA component inspectors to meet new FDA oversight of the OTC cosmetic industry.

•Worked with upper management from the first day on the job, reporting directly to the CEO with any problems and the solutions I identified were implemented by me after approval.

•Levlad grew from a fifteen million dollar a year company to a two hundred million dollar a year company because I was able to implement Total Quality Management (TQM) throughout the plant in response to yearly audits by (GR). By using Strength, Weakness, Opportunity and Threat (SWOT) analysis, I was able to determine where our resources would create the largest Return of Investment (ROI) based on existing and projected sales.

•Lead cleaning validation for Guthy Renker (GR) OTC products along with Levlad OTC Suncare products and three other OTC products.

•Validated the OTC processes from compounding (BME) to filling (Content Uniformity) for Suncare and Acne care products.

•Created and validated the Stability program and validated the new DI water system.

•GR increased their monthly business from 300,000 units a month to over 8,000,000 units per month of their three key products of their Activ line. GR also brought in their other product lines, (Cindy Crawford, Victoria principle, etc.) for Levlad to produce.

•Groomed other customers, such as Arbonne which grew more 300% in four years.

•Levlad has their own brand, Natures Gate, and I worked closely with R&D and sales and the USDA when they became Organic based products.

•Revised and wrote new SOPs, methods, and lead training in support of creating a continuous flow manufacturing plant.

•Released product and reviewed and signed COA’s

Quality Specialist (temporary)

Baxter Labs Glendale, CA

Injectable Drug Manufacturer 05/1999 - 05/2000

•Hired to validate the expansion of the Factor 8 (Hemophilia) plasma line

EDUCATION

St Paul VoTech Lab Tech program - Completed

University of Minnesota – Twin Cities Campus – Completed 2 years toward a BS in Chemistry

CERTIFICATIONS

Member American Society of Quality (ASQ)

•ASQ Six Sigma Green Belt (December 2013)

•ASQ Certified Manager of Quality/Organizational Excellence (March 2012)

•Attended FDA seminar for new regulations of OTC labels. (March 2005}

Instrumentation

Aligent HPLC, UPLC, GC/MS, AA

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