Medical Device Quality Assurance

Amy M. Kang

**** ******* ** - ******* *******, Il 60169

Phone: 630-***-**** - *********@*****.***

EDUCATION

DePaul University Chicago, IL

Sept 2004-2008, BS in Biology, minor: in Chemistry,

Statistics and Fine Arts

EXPERIENCE & TRAINING

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Baxter Healthcare Round Lake, IL

Feb 2013 - May

2013

Global Product Surveillance Quality Associate I

Participate in Corporate Sterility Assurance remediation activities related

to FDA 483 observations at North Cove Manufacturing Facility using cGMP

(current Good Manufacturing Practice) and industry standards for classified

rooms.

. Work with IMD (Instantaneous Microbial Detection) technology to

evaluate and monitor manufacturing clean room environments (class

100000) to support parametric release.

. Assist Corporate Sterility Assurance in developing environmental

monitoring protocols. Activities include: walkthroughs of

manufacturing areas, touch-point analysis, and analysis of IMD data.

. Conduct real time risk assessments to identify risks of microbial

ingress and proliferation in the terminal sterilization filling

environment

. Participate in cross-functional teams and meetings with Senior

Leadership to assist with status updates and to determine future

actions to mitigate risk.

. Evaluate and mitigate potential sources of microbial risk by

requesting evaluation bioburden samples, Critical Work Requests

(CWRs), Environmental Maintenance Requests (EMRs) and Environmental

Deviations (EDs).

. Collect microbial surface samples for environmental monitoring of

manufacturing clean rooms

Baxter Healthcare Round Lake, IL

Oct.2010-

Present

Global Product Surveillance Quality Associate I

Post-Market Surveillance for Renal Peritoneal Dialysis products

(HomeChoice, Disposable Sets, and solution bags) this data can include but

is not limited to, customer concerns, complaints, and inquires.

. Review and Processing Customer Complaint.

. Maintain current knowledge of FDA regulations of medical device

reporting.

. Submit electronic medical device reports (MDRs) for FDA notification.

. Communicate with patients to obtain product information for

investigations.

. Managing work Flow

. Support process improvement activities and projects.

. Mentor coworkers for further processing of complaints.

Plasma Biological Services Elgin, IL

Aug. 2009-Apr 2010

Quality Assurance Coordinator

. Provide training to the quality department employees and the floor

staff (e.g., Original Documentation Practices, Standard Operating

Procedures, Quality Leadership, QA Database, etc.).

. Monitor Plasma Bank Floor activities to maintain and adhere quality

standards (donor entry, phlebotomy floor, plasma storage, new donor

testing lab, and shipping)

. Assist with audits of various reports (Protocols, Qualifications,

Regulatory Submissions, etc.). Identify areas of non-conformance.

. Participate in internal or external assessments, as required. Assisted

in processing timely closure of observations/audit items.

. Review documentation for accuracy and compliance to procedures

DePaul University

Apr 2007-Nov 2007

Undergraduate T.A.for General Biology I

. Lab preparation and setup

. Provide assistance to faculty members or staff with laboratory work

. Lead discussion and study group for students

. Assist with visual aids, answer keys and quiz grading, supplementary

notes and etc

. Inform students of the procedures for completing and submitting class

work such as lab reports.

Wheaton North High School

Sept 2007 - Nov 2007

Intern, Athletic Training Services

. Basic first aid skill sets: immediate care and clinical assistance to

the Head Athletic Trainer

. Assistance with rehabilitation and recondition of Athletes

. Assist setting up sports events

SKILLS

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. Proficient on Word, PowerPoint, Excel, and Outlook.

. Lab: light microscopy and slide preparation, simple stains, gram

stains, whole mounts, aseptic transfer and pipetting of microbial and

phage cultures; aseptic manipulation of broth and slant cultures as

well as streak, spread, and pour plate techniques, preparation and pH

adjustment of solutions and buffers, gel electrophoresis, paper

chromatography, wet chemistry

Contact this candidate