Wendie Bernard is a highly organized Quality Assurance Professional with experience in the biotechnology industry. She has hands-on experience executing tests and analyses, training others, and leading cross-functional teams to solve problems. She is Green Belt certified in Lean Six Sigma and has various additional certifications in quality auditing and cGMP practices.

1. W E N D I E M . B E R N A R D
24 LA KE STREET , SPEN CER , MASS AC HU SETTS 01562
(508) 789-7371 | wjtiggr@aol.com | www.linkedin.com/in/wedie-bernard-02047725
S U M M A R Y
Highly organized, results focused Quality Assurance Professional with hands-on experience in the
biotechnology industry. Keen eye for analyzing problems and determining viable solutions. Dynamic team
leader with experience as a qualified trainer in aseptic technique and environmental monitoring processes.
H I G H L I G H T S
• Green Belt Certified in Six Sigma • Environmental Monitoring Lead • Train the Trainer Course
• Aseptic Technique Qualified Trainer
• Lean Six Sigma
• Safety Committee Member
• 6S and Visual Controls
• Data Trending with JMP
software
P R O F E S S I O N A L C E R T I F I C A T I O N S
QUALITY AND PRODUCTIVITY SOLUTIONS, INC (QPS), Marlborough MA 2014
American Society for Quality (ASQ) accredited;
• Certified Lean Six Sigma Green Belt, Certificaton # QPS041114-6
• cGMP-Pharmaceutical Certification, Certification # QPS041614-3
• ISO 9001:2008 Auditing, Certification # QPS042314-3
• CBA- Certified Biomedical Auditing, Certification # QPS050914-2
• CQA-Quality Auditing, Certification # QPS051614-2 ASQ Certified CQA- Certification # 47730
B I O T E C H N O L O G Y E X P E R I E N C E
ALEXION PHARMACEUTICALS, formerly SYNAGEVA BIOPHARMA, CO. , Holden MA 2014-2016
QC Analyst II, Microbiology (Contractor)
• Executed Bioburden, Endotoxin KQCL with the Spectromax plate reader, Growth Promotion/Sterility of
media. Reviewed and prepared data for trend analysis.
• Prepared samples for Microbial ID and Viral PCR for contract testing in accordance with SOP's.
• Accomplished a 100% reduction of the 6 month backlog of Viral PCR samples within 2 months for both
Holden MA customers.
• Reduced 6 month backlog of Bioburden samples to a current status within 2 months for one of Holden
MA customer’s products resulting in a 50 % backlog reduction. With a final reduction of 100% of all
backlog samples for both product lines within 6 months.
• Performed gap analysis on current department SOP’s, composed new procedures using technical writing
techniques to comply with cGXP guidelines. Implemented all of Training procedures for the Quality
Control Methods.
• Completed OOS and Deviation investigations to comply with cGXP procedures and current regulatory
guidelines.
• Composed and executed Bioburden Method Validations for Upstream Manufacturing Processes.
• Collaborated with cross-functional teams and outside contract facilities to optimize the feasibility of
product filtration for rapid Bioburden enumeration.
• Root Cause Analysis and Technical Writing training through Path Wise Consultants.
• Pipette Proficiency training with ARTEL.
• Aseptic Technique and Environmental Monitoring training with Microbiology Research Associates, Inc.
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2. • IATA training through SafeTPak.
W E N D I E M . B E R N A R D
(508) 789-7371 | wjtiggr@aol.com | www.linkedin.com/in/wedie-bernard-02047725
LONZA BIOLOGICS INC., Hopkinton MA 2010-2013
QC Analyst III, Microbiology
• Executed Bioburden, Endotoxin Gel Clot, KQCL with the el808ex plate reader, Conductivity, Color and
Appearance, Total Organic Carbon, and Nitrate assays as well as Growth Promotion/Sterility of media,
Culture Purity and Cell Viability assays, initial training in Raw Materials compendial testing per
USP/EP and the utilization of PH meter.
• Performed environmental monitoring which included the monitoring of Process Gas and Nitrogen
Systems, Manufacturing Clean Rooms, and Water Systems by following GMP protocols and EHS safety
practices.
• Obtained SME status on EM group equipment and processes; as well as Qualified Aseptic Qualification
trainer, worked with cross-functional teams to streamline the aseptic qualification program to be more
detailed and to reduce failure rate by 50%.
• Initiated deviations, CAPAs, OOS, and assay failure reports; and participated in investigations.
• Performed daily reporting, recording, and reviewing of EM and Assays data.
• Decreased 2 year backlog of Bi-Annual trend reports to 100% completion using JMP, by extracting data
from Excel, LIMS, and MODA databases and manually creating data trend graphs to comply with
Regulatory requirements.
• Used, cleaned, maintained, and supported Metrology with the timely calibration of Micro department's
equipment such as lab pipettes, Climet, Draegers, RCS, SAS, and timers.
• Played an intricate role in the lab operational excellence program, organized and designed lab work
stations while contributing to lab 6S program, which increased work proficiency by all analysts.
SECON OF NEW ENGLAND, Worcester, MA 2007
QUALITY / SAMPLE TESTING ASSOCIATE II
• Performed Oral Fluid screening with Orasure, and International diagnostic kits by utilizing extensive
pipetting of samples; in conjunction with an Elisa technique.
• Utilized and performed drug screens on the EVO Tecan and Elisa; as well as proficiently running urine
screens on the Abbott Axsym Systems to obtain 100 % 24-hour result turn around.
• Collaborated with Tecan Elisa System designer to design and implement a program to automatically
pipette samples into Elisa sample plates for the microplate reader to increase efficiency and production.
• Maintained required Elisa QC and Oral Fluid requisition data packets on a routine basis.
R E T A I L E X P E R I E N C E
KAY JEWELERS, Boston and Central MA Districts 2000-2010
Over the course of a 10 year employment, positions were held within three stores in the Boston and Central MA
Districts. These stores generated between $1.5M and $3M in sales annually.
Office Manager and Sales Associate (2009-2010)
Store Manager (2007-2009)
Premier Sales Associate/ Office Manager (2003-2006)
Assistant Manager (2002-2003)
Entry Level Sales Associate (2000-2002)
• Maintained monthly and yearly sales standards by providing customer service and special order support
as well as a running a profitable repair department through increased jewelry repair sales.
• Organized office supplies and maintained accounts receivable, inventory, and loss prevention controls.
• Recruited, managed, trained, and developed nine sales associates.
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3. • Developed and implemented small marketing ideas for store special events to generate sales.
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4. W E N D I E M . B E R N A R D
(508) 789-7371 | wjtiggr@aol.com | www.linkedin.com/in/wedie-bernard-02047725
S O F T W A R E
Proficient in: Microsoft Office (Word, Excel, PowerPoint), LIMS, MODA (MODA Data Acquisition),
TrackWise, SharePoint, Jump (JMP5), and SAP.
E D U C A T I O N
WORCESTER STATE UNIVERSITY, Worcester, MA
B.S., Biology, Psychological Studies Minor
Coursework in Biology and Early Childhood Education
A F F I L I A T I O N S
American Society for Quality Assurance (ASQ), with additional membership in the Quality Audit and
Inspection Divisions, 2014.
R E S E A R C H E X P E R I E N C E
Independent Study and Expedition to the Galapagos Islands (2006)
Topics of study included marine and island wildlife, as well as the geological formation of the Islands.
V O L U N T E E R W O R K / A D D I T I O N A L A C C O M P L I S H M E N T S
Spencer East Brookfield Spring 2014 T-Ball Organization- Team Mom/Assistant Coach
5K Run or Dye for a cause June 2014- Charitable Fundraiser for American Cancer Society
Foster Parent to two Kinship pre-teen girls from the Massachusetts Department of Children and Families for 10
months in 2014-2015.
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