Quality Assurance Assistant

KRISTIAN ASHE

**** ********* *** **********, ** *0039 ********@*****.*** 678-***-****

EDUCATION:

Emory University Atlanta, GA 5/2008

Bachelor of Science, Chemistry

EXPERIENCE:

Speed Laboratory Buford, GA 01/2014 Present

Lead Quality Assurance Chemist

● Responsible for analytical testing on a wide variety samples like polymers, pharmaceuticals,

homeopathics, environmentals, and medical devices using a variety of chromatographic and analytical

techniques in a GMP/FDA regulated laboratory.

● Provide analytical support, including product and intermediate characterization, method development and

validation, and routine testing using HPLC, GC MS, UV Vis, and other analytical instrumentation.

● Develop, optimize, and validate experiments in compliance with applicable SOPs and regulations for new

customers.

● Actively review analytical data to ensure consistent, timely delivery of high quality and accurate information.

● Scheduled work and testing to maximize efficiency report any late projects to Quality Assurance supervisor

for notification to client services.

● Analyzes diverse analytical data and interprets the results.

● Maintain laboratory notebooks, logbooks, forms and other records and documentation as required.

● Provide certificates of analysis, analytical results reports,Out of Spec reports and/or summaries for internal

and external clients.

● Identifies and implements opportunities for continual improvement in the delivery of services.

● Addresses unanticipated issues and problems in an expedient, efficient and cost effective manner.

● Coordinate the maintenance, upkeep, calibration and qualification of analytical instrumentation. Interact with

instrument manufacturer's technical service when appropriate.

● Perform all responsibilities in accordance with company guidelines, SOPs and protocols and appropriate

industry, quality and regulatory standards, guidelines, rules and regulations.

● Rework and edited SOPs of the Analytical Department to follow guidelines of FDA and ICH.

CIBA VISION Johns Creek, GA 08/2013 01/2014

Laboratory Technician/ Assistant Contract

● Perform logistics and execution of manipulations for a key research projects.

● Set up lab stations, in an ISO 17025 approved labs, for cyclers and ensure that materials needed are

available.

● Have the ability to compound some solutions in the lab based on given operating procedures.

● Perform audits of products to be handled and provided to the test labs.

● Work with managers to assure that required resources are available in advance.

● Adhere to strict timelines and GDP

Wrigley Flowery Branch, GA 04/2013 08/2013

Quality Assurance Associate/ Chemist Contract

● Performed scientific analyses on a food and drug samples in a ISO 2001:2008, ISO22000 and Dutch

HACCP approved lab.

● Independently operated maintained and performed trouble shooting analytical instrumentation such as

HPLC, GC, UV Vis, FTIR, NIR, DSC.

● Proficient with compendial wet chemistry procedures from FCC, AOAC, USP, etc. and have an

understanding of compendial testing guidelines.

● Perform analytical testing in support of New Product Development, Factory Support, and other business

needs

● Performed peer review of analytical results and calculations generated by the lab. Provided technical

assistance and insight (method equipment, or technique related) for the Innovation Team as well as Global

Customers (i.e. Factories or Satellite locations).

● Assisted/lead lab related projects, activities i.e. test method validation and performed technical writing for

the generation of Standard Operating Procedures, COAs, test methods, project reports, or other Laboratory

or Quality Protocols.

● Provides technical assistance and insight (method, equipment, or technique related) for the Innovation

Team as well as Global Customers (i.e. Factories or Satellite locations)

● Managed data appropriately and effectively. This includes the accurate reporting of data and the appropriate

management of out of spec or aberrant data. Was an active participant in a flexible team environment and is

expected to drive and implement laboratory continuous improvement initiatives.

● Selected the appropriate methods and procedures for projects documenting any modifications if needed

● Prepared scientific reports records in detail the receipt handling and analysis of samples and participated

in firm inspections to assist, observe and evaluate manufacturing processes, practices and conditions.

Mikart Inc. Atlanta, GA 04/2011 02/2013

Quality Control Analyst

Responsible for preparing, performing, and documenting analyses on incoming in process, raw material,

finished product, and/or stability samples in accordance with Mikart specifications and procedure

• Experienced in the use of all laboratory equipment used in routine sample analyses (for example, UV VIS,

FTIR, Karl Fisher tritator, pH meter, drying oven, Anton Paar for specific gravity, and dissolution apparatus

for finished product and stability testing) and the use and operation of HPLCs equipped with integrators, and

with Empower 3 software.

• Performed sample prep for GC analyses, and the use and operation of GCs equipped with Chemstation

software.

• Participated in discrepancy investigation resolution procedures

• Experience working, writing and testing procedures in a GMP QC laboratory environment.

• Selected the appropriate methods and procedures prepared scientific reports recorded the receipt handling

and analysis of samples and participated in firm inspections to assist, observe and evaluate manufacturing

processes, practices and conditions.

• Prepared scientific reports identifying the sample and stated the methods and procedures used,

modifications of the method including validation data, and the results.

• Supervised and coordinated the destruction for all Non Controlled Substance in the Stability Department.

Gwinnett County Public Schools Gwinnett County, GA 5/2008 – 4/2011

Science and Math Substitute Teacher for Middle and High Schools

● Created stimulating activities that followed permanent teacher's lesson plans

● Learned skills to successfully manage classroom/behavior situations.

● To provide a safe and secure learning environment for students.

Center of Disease Control Clifton Campus Atlanta, GA 12/2006 – 05/2008

Intern/ORISE Fellowship

Found and identified different outer membrane genes in a newly sequenced genome of Orientia

tsutsugamushi, a causative organism of scrub typhus that is transferred by mites. Annotated 80% percent

of the genome by cross referencing with closest complete sequenced family member, Rickettsia. Used

gel electrophoresis and real time PCR to further identify and test interest protein sequences.

● Assisted with genetic and western blotting comparison of Rickettsia in species and Orientia.

● Assisted with PCR, gel electrophoresis, and expression of diagnostic antigens and monoclonal antibodies.

● Learned to master various bioinformatics programs such as NCBI BLAST, KEGG, UniPort, PSORT,

CLUSTALW, MetaPP, Oligo 6, and many others.

TRAINING: Agilent Technologies: Gradient Design and Development, Gradient Separations, SPE and

Quechers, and GC Troubleshooting.

COMPUTER SKILLS: Empower 3 software, Chemstation software, Microsoft Office, and Macintosh Platform

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