DEBORAH L. HENDRIKSEN-WAWRZYNIAK

***** **** ******** *****

Mundelein, Illinois 60060

847-***-****

aczffu@r.postjobfree.com

linkedin.com/in/deborahwawrzyniak

SUMMARY

Accomplished Quality professional with twenty-eight years of experience in leading supplier and change management. Proven Quality leader with pharmaceutical, device, nutritional and nutraceutical experience in global markets. Results oriented manager with over eighteen years of supervisory/managerial responsibility.

EXPERIENCE

ABBOTT, Abbott Park, Illinois

Quality Assurance Manager: Supplier, TPM, Advertising and Promotions, Abbott Animal Health, 2008-2016

Developed and executed quality plans while monitoring and mitigating risk concerning suppliers and third party manufacturers. Identified gaps and implemented corrective and preventive actions for quality system compliance. Performed QA lot sampling, inspection, investigations and product release. Evaluated product quality review data for potential process control and specification changes. Assessed change events to ensure change impact evaluation across quality system and negotiated quality agreements.

Leveraged resources to facilitate AAH supplier program by ensuring 73% of 2014 on-site audits were shared with Abbott divisions and assessed an additional 10% of supplier/service provider base approval through questionnaires. Improved supplier monitoring by incorporating cross-functional team feedback to determine key performance indicators and align company’s-TPM expectations. Re-classified supplier base using a risk- based approach.

Streamlined supplier change notification process as input into change management program. Triaged and reduced number of non-value added change notices by 44%.

Ensured product requirement incorporation into product launches. Reviewed or created validation protocols, specifications, test results, design inputs/outputs, labeling and advertising. Incorporated quality agreement review into audit plans and implemented purchase order blocks as needed.

Assumed distribution quality assurance responsibilities in 2013 and collaborated with contract and public warehouses to ensure product integrity in supply chain. Developed and implemented product handling requirements in supply chain. Managed primary warehouse environmental qualification and monitored warehouse material moves during 2014 polar vortex as a preventive action to ensure no impact to product quality.

Launched ICAT, a cloud-based data management system for life-cycle management of advertising and promotional (A&P) literature commodities. Optimized A&P process through procedures, training, IQA, print vendor on-site audits and defining functional group approval responsibilities. Oversaw websites, smart phone applications and on-site print productions though workflows to meet stakeholder timelines.

cGMP Compliance Officer, Abbott Animal Health, 2005-2008

Facilitated third party manufacturer and internal audits. Identified and implemented corrective and preventive actions for drug product and medical device complaints and trends. Verified monthly and CAPA reports.

Compiled and presented management review information.

Provided record retention/document change control support and established defect recognition/product quality review programs.

Manufacturing Quality Assurance Section Manager, Abbott Animal Health, 2002-2005

Collaborated with internal and external suppliers to facilitate complaint closure. Ensured labeling deliverables met project timelines while facilitating third party manufacturer audits. Identified and implemented corrective and preventive actions for drug product and medical device complaints and trends. Created monthly and CAPA reports. Compiled and presented management review. Performed IQA lot sampling, inspection and release.

Improved incoming quality assurance processes concerning multiple lot receipts, pre-shipment samples, defect recognition training, sampling and quality holds.

Redefined advertising and promotional material approval process.

ADDITIONAL EXPERIENCE

Supervisor, Standards and Specifications, Specialty Products Division, 1999-2002. Served as steering committee representative for procedure redesign project. Implemented competency based monthly peer surveys. Participated in Documentum workshops to determine functional requirements and established user acceptability testing.

Specification Editor, Standards and Specifications, Specialty Products Division, 1997-1999. Managed approval, authority and division reorganization project in preparation for agricultural business unit sale. Updated Documentation change control module to increase compliance.

Associate Analytical Chemist, Reference Standards, Specialty Products Division, 1993-1997. Created reference standard training, chromatographic guidelines and shipping library. Trained reference standard personnel on dispensing and shipping procedures. Redefined reference standard liaison program and facilitated reference standard training sessions globally.

Quality Assurance Laboratory Technician, In-Process and Finished Products, Chemical and Agricultural Products Division, 1987-1993. Developed guide to data acquisition using PE Nelson Access Chrome. Implemented instrumentation safety features and improved laboratory safety program, resulting in zero OSHA reportables or lost time accidents during two-year period.

EDUCATION

RIPON COLLEGE, Ripon, Wisconsin, B.A., Chemistry, Biology, Chem-Bio, 1987

CERTIFICATIONS

ISO 9001:2000 Lead Auditor with Medical Device Focus-ISO 13485, 2007

Certified Quality Auditor, 2002

Certified Manager of Quality/Organization Excellence, 2002

PUBLICATIONS

Aberrant SRN1 Reaction of 4-Aminophenol with alpha, para-Dinitrocumene: EPR 2000 Observation of Intermediates.

Scamehorn, R.; Mahnke, L.; Krause, R.; Frey, B.; Hendriksen, D.; Jahn, K.; Kultgen, S.; Walton, J.; Organic Letters, Vol 2, number 6

AFFILIATIONS

ASQ

COMPUTER SKILLS

Microsoft Office Suite, Lotus Notes, IsoTrain, M-Files, DMS (Citrix), SharePoint, ICAT (Veeva Vault), GQMS (NetRegulus)

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