Quality Assurance Manager

*** ***** **** • LIGONIER PA *****

PHONE 724-***-**** • E-MAIL *******@*********.***

LORI L. BAKER

O BJECTIVE

To obtain a professional and rewarding position as a Quality Assurance Manager utilizing my

education, employment experience and leadership skills to drive the companies mission in ensuring a

compliant and safe work environment.

E DUCATION

May 2007 to Present Seton Hill University [ City, State

Credits earned towards Bachelors Degree in Business

Current overall GPA 3.93

May 2007 Quality WBT Center for Education

Auditing (CQA) Fundamentals I & II

Certificate of Completion

June 2007 Drew Institute

Problem Solving Workshop

Certificate in Stat-a-matrix Basic Problem Solving & Intermediate

Problem Solving

January 1998 Western School of Health and Business

Phlebotomy

Certificate in Phlebotomy

P ROFESSIONAL EXPERIE NC E

October 2004 to Present American Red Cross [ City, State

Quality Specialist/Quality Assurance Associate

Current duties include: Supervising and overseeing staffs in all

departments within the region; reviewing and closing all levels of

deviations in the automated problem management system; involvement

on problem teams to improve weaknesses by performing root cause

analysis, and developing corrective actions and effectiveness checks;

reviewing and approving correction action plans; identifying problems;

performing internal audits of all departments throughout the Greater

Alleghenies Region; hosting Food and Drug Administration audits,

hosting internal National audits, performing reviews of qualifications for

equipment and hardware; Reviewing Qualification and Validation plans

for equipment, Performing recalls and market withdrawals of blood

products; Reporting Biological Product Deviations to the Food and

Drug Administration; Facility administrator for Smart CAPA deviation

tracking system; Instructor and trainer for Smart CAPA deviation

procedures, Performing query and reporting for trend deviations;

utilizing Webi reports to track problem timelines; knowledge of Code of

Federal Regulations and AABB Standards; typing and submitting reports

for the Material Review Board for product disposition approval and

Regional Quality Assessor for the Quality Walk thru process (assessing

all staff on the ability to perform walk thru audits).

August 2003 to October 2004 American Red Cross

Quality Secretary

Duties included: Data entry of all problems into the Deviation Tracking

System, DTS; tracking timelines for Corrective Actions and

Effectiveness Checks, filing; maintaining QA procedural binders;

distribution and tracking memos of acknowledgement and

understanding; periodic binder audits; assisting in recalls and market

withdrawals; trained in changed controls and donor call backs; collecting

blood samples from new employees for Tider testing and typing letters

to consignees for recalls and market withdrawals.

February 2000 to August 2003 American Red Cross

Technical Services Specialist

Duties included: Labeling blood components; quarantining blood

components; adding properties and holds on blood products; packing

and shipping sample tubes to NTL; maintaining equipment; daily QC on

equipment; waste management of biohazard and unsuitable blood

components; handling donor call-backs; collecting blood specimens;

operating and monitoring CAMs system(temperature monitoring

system) and reconciliation of all units of blood.

February 1998 to February 2000 American Red Cross

Phlebotomist

Duties included: Venipuncture; setting up and breaking down of blood

mobiles; customer relations; donor reaction care; daily QC on

equipment and travel.

M ANAGEMENT/ V OLUNTEER EXPERIENCE

January 2006 to Present Ligonier Township Authorities

Wilpen Playground Committee Co-Leader

Co-Leader for Wilpen Playground Committee, non-profit organization that

operates under Ligonier Township Authorities. Responsible for

developing, organizing and implementing fundraiser events; motivating and

recruiting volunteers; ordering playground equipment; recruiting support

from local business, assisting in grant applications; working in teams;

facilitating meetings; ensuring funds are applied to appropriate grant

requests and providing guidance and direction to volunteers.

January 2009 to Present Seton Hill University

President of Alpha Sigma Lambda; National Adult Honor Society

Plans and facilitates all meeting. Plans and organizes induction and cord

ceremonies. Leads outreach committee, fun committee and fundraising

committee. Tracks and maintains ASL scholarships recipients. Ensures

budget is maintained.

References are available upon request

Contact this candidate