Chemist

Kathy Gerst

*** **** *****

Windsor, CO *****

Phone: 816-***-****

Email: **********@*****.***

PROFESSIONAL EXPERIENCE

IBA Molecular

Oct 2012 - current QAO / QC Chemist, Kansas City, MO

. Quality Assurance Officer, GMP compliance auditing

. QC Chemist, laboratory testing of PET Pharmaceuticals, HPLC, GC, TLC,

etc

. Production Technician of PET Pharmaceuticals

. Operation of cyclotron

. Scientific writing of SOPs, CAPAs, OOSs, and Deviations

. Checking reports, batch records, & daily logs for accuracy and

compliance

. GMP / GLP compliance

Gashland Clinic (Part-time)

Jan 2013 - current Medical Technologist Kansas City, MO

. Perform clinical laboratory testing including blood chemistry,

hematology, and coagulation

. Perform phlebotomy, urine analysis, data entry, and review.

. GCP Compliance

Albaugh / Lab Tech Consulting (6 month contract)

Mar 2012 - Sep 2012 Chemist, St. Joseph, MO

. QC Chemist, laboratory testing of farm chemicals, HPLC, GC, etc

Quintiles / Assent Consulting (6 month contract)

Aug 2011 - Feb 2012 Clinical Data Coordinator, Overland Park, KS

. Data Entry for Clinical Trials

. Data Review of Clinical Trial Studies

cGMP Validations (contract position)

April 2011 - Aug 2011 Validation Specialist, Shawnee, KS

. Set up Validations of Instrumentation and Methods at various companies

. Data Review and Protocol writing

Lloyd Inc

Nov 2010 - Feb 2011 Senior Scientist, Shenandoah, IA

. Performed Normal and Reverse Phase HPLC analysis on pharmaceuticals

. Performed method development, validation, and transfer of HPLC assays

. Scientific writing of protocols, methods, and reports

. Performed testing of stability samples as well as release samples

. Experience with Microsoft Office software including Excel, Word,

Powerpoint & others

. GMP/GLP Compliance

Aptuit / Quintiles

July 2008 - Feb 2010 Aptuit - Scientist Harrisonville, MO

Oct, 2005 - July 2008 Aptuit - Scientist Kansas City, MO (company

name change due to purchase)

May 2004 - Oct, 2005 Quintiles - Research Chemist Kansas City, MO

July 1999 - May 2004 Quintiles - Associate Research Chemist KC, MO

. Project technical lead and group manager

. QA Auditing of reports and files generated in other sections of

Aptuit/Quintiles

. Scientific writing of SOP, protocols, methods, and reports for

accuracy and compliance, including CAPAs and OOSs

. Performed method development, validation, and transfer of HPLC assays

. Performed Normal and Reverse Phase HPLC (chiral & achiral) analysis on

pre-clinical pharmaceuticals and APIs

. Performed testing of stability samples as well as release samples

. HPLC instrument troubleshooting

. HPLC, GC, Karl Fisher, FTIR, TLC, etc analysis

. Raw material testing for API manufacturing

. Experience with Microsoft Office software including Excel, Word,

Powerpoint & others

. GMP/GLP Compliance

Midwest Research Institute (MRI)

March, 1994 - July, 1999 Associate Biologist / Med Tech Kansas

City, MO

. Performed quality assurance audits of files generated in other

sections of MRI

. Participated in FDA and client audits, including direct questions and

performing lab work.

. Supported NCI studies of potential anticancer and anti-AIDS compounds

and product safety assessments for private sector clients

. Assisted on target animal safety assessment studies of veterinary

pharmaceuticals and insecticides

. Performed clinical laboratory testing including chemistry, hematology,

coagulation, and phlebotomy

. Immunoassay & Elisa Analysis

. Assisted with human health studies for phase 1 and phase 2 clinical

trials and data analysis

. Assisted in method development, transfer, and validation for clinical

trial assays

. Assisted with in pharmacokinetics, metabolism, and toxicology studies

including set-up, formulation, dose preparation, sample collection,

data capture, and review

. Assisted in sample preparation for HPLC and GC analysis as well as

data collection and review

. GMP/GLP/GCP Compliance

REMEL Laboratory

May, 1991 - February, 1994 Formulations/ Raw Materials Technologist

Lenexa, KS

. Performed chemical evaluations on raw materials and prepared media

. Evaluated media for growth, selectivity, and biochemical performance

of target microorganisms

. Adjusted classical microbiological media formulas to improve

reactions.

. GMP Compliance

Vining & Eastridge Medical Laboratories

April, 1989 - May, 1991 Medical Technologist St. Joseph, MO

. Performed clinical laboratory testing including blood chemistry,

hematology, coagulation, and microbiology

. Performed phlebotomy, urine analysis, data entry, and review.

. GCP Compliance

Education: December, 1988

B.S. Majors: Biology & Mathematics

Minor: Chemistry

Missouri Western State University, St. Joseph, MO

Certifications: Medical Technologist as approved by the Health Care

Financing Administration (HCFA) and the Department of Health and Human

Services (HHS) as outlined in the Clinical Laboratory Improvement

Amendments of 1988 (CLIA 88, Section 493.1433 Part 3) & Phlebotomy

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