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QC Specialist

Location:
Gainesville, GA, 30506
Posted:
February 01, 2017

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Original resume on Jobvertise

Resume:

Kayla Scroggs

**** *** ***** **. ***********, Ga 30506

Phone: 678-***-****

E-mail: acyldc@r.postjobfree.com

Objective

I am seeking a position in a company where I can use the skills I have obtained through my biotechnology degree

and experience in the pharmaceutical industry for the betterment of the organization and improvement of patient

lives.

Skills

Follow, write, revise and update SOPs in accordance to FDA requirements.

Maintaining GMP and non-GMP material inventory.

Logbook review.

Laboratory and instrument cleaning and maintenance.

Proper disposal of biohazardous waste. (Neutralization, autoclave, etc.)

Environmental monitoring.

Aseptic technique.

Train and mentor new hires in last three positions.

MS Office, LIMs, Oracle, ERP, CatsWeb, BMRAM.

Lab safety (5+yrs W/O any safety incidents).

Excellent teamwork and communication.

Experience

QUALITY CONTROL SPECIALIST-BIOASSAY (01/15 Present)

Dendreon/Valeant (Union City, GA)

Perform routine and non-routine analysis of in-process, finished products and raw materials

during release or stability testing.

Manage test samples, reagents and raw materials used in the laboratory per approved procedures.

Regularly perform the following assays: CBC, Viability, Gram Stain, Endotoxin, ELISA-Identity, and Flow

Cytometry.

Data analysis, management, audit and trending.

Generate and approve In-Process and Final Product COAs.

Write LIRs, NCs and CAPAs.

Kayla Scroggs

Reagent preparation and qualification.

Perform testing in support of method validation studies.

Pipette verification.

Collaborate with QA to maintain the quality system.

Represent QC department.

CELL PROCESSING ASSOCIATE II(12/10 01/15)

Dendreon (Union City, GA)

Aseptic manufacturing and assembly of clinical and commercial human blood derived

components in a clean-room environment (Class 10,000/ISO7, and Class 100,000/ISO8).

Weigh, measure and check raw materials to ensure batches manufactured contain proper ingredients and

quantities.

Maintain records to comply with regulatory requirements and act as subject matter expert for revisions or

improvements to manufacturing documents.

Represent department in cross-functional teams, projects and GXP-related problem resolution.

Gown aseptically for work in a Clean Room environment.

Shipping and receiving.

Head of verifier training and aseptic practices programs.

Lead batch record correction reduction project.

SHIFT SUPERVISOR (07/09 12/10)

CVS Pharmacy (Gainesville, GA)

Opening and closing store.

Supervise cashiers.

Customer service.

Inventory and stocking.

Education

Associates Degree of Biotechnology (05/10)

Page 2 acyldc@r.postjobfree.com 678-***-****

Resume: Kayla Scroggs

Athens Technical College (Athens, GA)

3.48 GPA

Biotech club member

Deans List Fall 2008, Summer 2009

Internship

Plant Pathology Lab (UGA)

Gene knockout construct.

Production, Transformation, and Screening of Protoplast.

PCR and DNA analysis.

Sterile media and solution preparations.

Sterilizations and sterile techniques.

Writing protocols.

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