Angela Bertasavage

Angela Bertasavage

Work History

Work History

Supplier Quality Engineer

Dec 2012 - Present
AZ Biologics,| Gaithersburg MD
Supplier Quality Engineer (Applied to new position-Promotion) Oversight Contract Manufacturers Non-conformances, Change Management, Audit Facilitation, Product Complaints External Network Regulatory Inspection Support Audit Facilitation/Participation of Contract Manufacturers and Laboratories; Due Diligence audits of OTLs and CMOs Rollout of SRM light programs QASM role for WWAG for OTLs and CMOs

Quality Control Planner

Jan 2012 - Dec 2012
MedImmune
| Frederick MD Quality Control Planner (Promotion) Ensure proper resource allocation for QC department by interpretation of metrics and data Preformed priority ranking of items excluded from the plan, showing which items to fund if more resources should become available; and there is a priority ranking of some items included in the plan, showing which items should be sacrificed if total funding must be reduced QC Lead on new incoming projects Mapped QC processes to determine relationships and optimize time spent on activities

Stability Coordinator

Aug 2008 - Jan 2012
MedImmune
Stability Coordinator Performed daily activities for the stability operations in support of analytical testing, quality, and manufacturing activities Prepare, execute and review stability time point pulls, data entry and/or review of stability results and overall operation of the stability group. Support the day to day operations of the current LIMS system for raw materials, validation, in-process and stability requirements as a Level 16 LIMS administrator.

Qc Technician

Jan 2004 - May 2007
MedImmune
QC Technician I/II (Promoted to II) Active role as LIMS administrator first 8 then 16 in addition to my regular role in the raw materials department Developed raw material specifications for clinical and commercial material Tested materials by USP and EP compendia methods Trained on and performed testing of HPLC, TLC and GC methods Login of raw material samples and scheduling of testing Inventoried all raw material retains Coordinated with outside lab facilities for testing in a timely manner Donor Network of Arizona| Phoenix AZ

Lab Technician

Mar 2001 - Dec 2002
MedImmune
Lab Technician Performed Human Leukocyte Antigen(HLA) testing Inventoried and collected monthly blood samples from patients on donor list Help to design custom LIMS system for unique lab Provided information to families concerning organ donation

Medical Lab Technician

Sep 1994 - Jan 2001
Pottsville Hospital
| Medical Lab Technician Main focus was in the Hematology department Performed chemistry testing including PT, PTT and Urinalysis Drew blood and performed BAC testing many time appearing in court Developed a system that cut out-patient time to get blood drawn by 25%. SKILLS Adept in Microsoft SharePoint, Visio, Word, Excel including the statistical Analysis Tool, Access and PowerPoint programs Working knowledge of Minitab, SAS and Microsoft Project

Education

Education

M.D

Hood College