Quality Engineer

Allysan Wielunski

*N*** Pleasant Ave. Glen Ellyn, Illinois 60137 630-***-****

**********@*****.***

Experienced Quality Engineer

Driving Process Improvement & Manufacturing Quality to protect consumers

A versatile quality and safety-focused team leader with more than 12 years

of proven success measuring, testing and analyzing consumer products from

formulation through packaging and shipping. Highly transferable skills

including building, supervising and cultivating top-performing teams,

reducing defective parts per million (DPM), eliminating waste and

optimizing processes for accuracy and efficiency. A performance-focused

problem solver and certified Six Sigma Green Belt, able to leverage

superior communications skills while performing root cause analysis,

implementing corrective actions and building knowledge management systems

and tools to standardize best practices. Able to draw on a wide range of

skills and experiences from the shop floor up to executive management to

achieve organizational objectives and exceed both quality and revenue

targets.

CAREER HISTORY

Avon Products, Inc. - Morton Grove, IL

December 2011 - Present

Quality Engineer

Recruit, mentor and lead a team of three engineers in evaluating roughly

20M units of consumer products (including facial creams, cleansers,

deodorants and cosmetics) prior to shipment to ensure all quality

standards, compliance with regulations and overall consumer safety.

Investigate and create non-conforming incident reports as needed. Review

and update SOPs. Perform internal quality reviews and audits.

. Successfully reduced DPM from 1500 to approximately 600 by increasing and

enforcing accountability.

. Enabled and supported the production of new items including 6.5M units of

the company's first nail polish.

. Mitigated risk to the organization and to consumers by implementing date

and time stamping on all tube cases.

. Spearheaded process improvements including a floor cleaning program which

reduced cross-contamination.

. Identified and resolved issues with damaged an opened products, in one

case selecting a new vendor for shower gel caps, which reduced leakage

and dropped DPM from 684 to 286.

. Recognized with a performance bonus for taking on additional

responsibilities related to pricing and costing new items for an interim

period of six months.

VFF Illinois Services, LLC (Formerly Dial Corporation) - Montgomery, IL

August 2009 - December 2011

Quality Specialist

Assisted in the seamless transition to new ownership by maintaining

continual quality and operations. Provided continual cGMP training for

production personnel. Collaboration with production to investigate non-

conforming material reports (NCMRs). Created, reviewed and trained staff on

SOPs and Work Instructions.

. Expanded role to include involvement and preparation for all FDA and in-

house quality audits.

. As part of Six Sigma Green Belt training, served as part of a team that

successfully corrected a quality defect related to soap bar wrappers and

also produced a substantial cost savings.

. Successfully responded to and resolved issues in a 483 warning letter

received from to FDA.

Dial Corporation - Montgomery, IL

2002 - 2009

Quality Specialist July 2007 - August 2009

Promoted to support daily authorization decisions for the release of up to

33K cases of bar soap and 16K cases of antiperspirant and deodorant.

Performed batch record audits. Utilized and updated Great Plains and LIMS

software systems. Initiated and finalized all NCMRs. Delivered ongoing cGMP

training, Investigated and resolved all consumer complaints related to the

facility. Reviewed Work Instructions, SOPs and related process

documentation. Supported quality audits.

. Served as a member of the American Society for Quality (ASQ).

Senior Quality Control Analyst February 2002 - July 2007

Performed quality testing of raw materials and finished products related to

the soap-making process. Utilized multiple wet-chemistry techniques.

Collaborated closely with R&D and other internal teams. Inspected and

approved packaging materials based on specifications. Composed and

organized quality documents including the generation and validation of

certificates of analysis (COAs) and SOPs. Ensured compliance with all site-

level policies and procedures. Maintained and conducted troubleshooting of

lab equipment.

. Selected to mentor and train for new technicians on all aspects of

testing.

. Researched, tested and implemented method improvements to Triclocarbon

(TCC) assay testing in collaboration with R&D, resulting in significantly

shorter testing times and less material waste.

EDUCATION & TRAINING

Bachelors of Science in Biology, DePaul University, Chicago, IL

Associate of Science in Biology, College of DuPage, Glen Ellyn, IL

Certifications

Six Sigma Green Belt

Software Skills

LIMS, SAP, Great Plains, JD Edwards EnterpriseOne, Microsoft Office

(including Word and Excel)

Laboratory Equipment

FT-IR Spectrometer, Density/Specific gravity meter, Chloridometer,

Labwave 9000

Testing & Analysis Skills

wastewater testing, pipetting and titrating, wet chemistry test methods,

aseptic sampling techniques,

calibration and standardization of lab equipment and analytical

instrumentation

Span of Expertise

- Quality Management Systems

- Project & Program Management

- Productivity & Process Improvement

- Efficiency & Waste Reduction

- System & Process Validation

- Team Leadership, Training & Mentorship

- Documentation & Standard Operating Procedures (SOPs)

- Complex & Innovative Problem Solving

- Safety & Risk Mitigation

- MSDS & Hazardous Material Handling

- Auditing & Non-Conforming Materials Investigation

- cGMP, GLP & USP Regulatory Compliance

- Change Management

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