lab tech/pharmaceutical/MLT

Quality Control (QC) Biologist

Pharmaceuticals/Medical Lab(ASCP)

Professional Objective

Professional Technician (ASCP) with 25 years of experience; including both

supervisory and Quality Control. Adept at performing scientific research

and analysis, arranging test reports and competently managing added lab

actions. Trackwise and SAP. Self-motivated, capable and hard- working

individual seeking to further career within the Pharmaceutical field and

build upon skills acquired in previous tenures.

Technical Skills

Adept in SAP and SRM

IBM Applications

Microsoft Office Suite: Word, Excel, Access and PowerPoint

Laboratory Equipment Platforms Including; Softmax Pro, Biocalc and a sample

tracking system

Internet Proficiency

Track wise and CAPA track wise

Knowledge of LIMS

Areas of Expertise

Centrifugation

Microplate Assays

Data Analysis/Management

Isoagglutinin Titers (A1 and B) For Chromatography IGIV

CMV ELISA

Tetanus Identity

Anticomplement Assay (100 CH50)

Rho-D (Gel Cards, Specificity and Identity)

Light Microscopy

Potency by MLA (coagulation) BCS, BCS/XP and Hamilton

Immunonephelometry

Buffer Preparation

Release Documentation for Batch Products

Summit/Amend Blanket and Standing Orders

Organized and Methodical

Team Player

Work Independently

Technical Writing

Second Check Documents

Knowledge of LIMS

Ordering Supplies

Analytical development

Method validations

UV-VISBLE SPECTROPHOTOMETER

TRACKWISE

Drawing blood

Trending quality control

Supervisor of office lab

Professional Experience

Kelly Services/Hospira ( Rocky Mount, NC)Complaint analyst-August 26,2013-

January 24th 2014 contract ended

Perform daily complaints by performing an investigation using Track wise.

Historical and CAPA searches, batch records, retains, within a 24-48 hour

time frame.

.

Grifols - Associate QC Biologist/Biochemistry - June 1999-November2012

Formerly Talecris and Bayer.

. Release testing of final products manufactured at the Clayton plant as

well as certain process intermediates

. Potency and identity testing for several process; intermediates and

final

. Anti compliment assays (100ch50), ELISAs (CMV), Immunonephelometry,

antigen and antibody complex assays (Rho-D) and automated assays

including the MLA, BCS,BCS/XP and Hamilton

. cGMPs and demands and time lines in the QC environment

. Performed routine lab inspections

. Attending safety meetings as a safety representative to the Clayton

HES Safety Committee

. Maintained the laboratory consumable and chemical inventory as well as

for ordering replacement items as necessary. Slashed payroll/benefits

administration costs 30% by negotiating pricing and fees, while

ensuring the continuation and enhancements of services.

. Collaborated with Analytical Development on Method validation project

for Rho-D ID on Provue

. Qualified Author

Professional Experience Continued

Olsten Staffing - Laboratory Support Technician - Raleigh Test Lab -

March1999-June 1999

. Production Support Department

. Batched and input data entry

. Processed samples for the PCR department

Wayne Heart and Internal Medicine - Medical Laboratory Technician (ASCP)-

September1998-March1999

. Performed routine testing of blood samples for glucose and cholesterol

and trending

Cardiovascular Consultants - Supervisor - Janurary1991-August1998

. Supervised 2 individuals (directly reporting)in doctors office lab

. Drew blood, tested and performed all trending

. Provided professional care for patients

. Participated in 2 CLIA inspections ( no violations)

Education and Training

Bachelor of Science - Clinical Laboratory Science - University of

Cincinnati - May2008

Associate of Arts - Laboratory Science/Medical Laboratory Technician -

Moraine Valley Community - May1987

Associate of Arts - Arts and Sciences - Moraine Valley Community - May1987

Joliet Junior College - 1985 transferred to Moraine Valley Community

College

References

Katy Pena -Hospira ****.****@*******.*** Phone 252-***-****

Beth Barnes-Grifols,Clayton NC ****.******@*******.*** Phone 919-***-****

Lisa Rice-Johnson County Schools, NC ********@*****.*** Phone 919-***-****

Valerie Langley-State of NC, **************@*****.*** Phone 919-***-****

.

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