Pharmaceuticals, Analytical, Regulatory, Quality Assurance

KARI M. SCHUTZ

**** ****** ***** 612-***-****

Deephaven, MN 55391 acfmwu@r.postjobfree.com

QUALIFICATIONS

Extensive experience in the Pharmaceutical Industry, with strong regulatory

knowledge in cGMP compliance, USP guidelines, FDA regulations, EU

directives, SOP preparation, streamlining of procedures, and general CMC

and non-clinical principals. Strengths include organizational skills,

creativity, flexibility, strong work ethic, ability to achieve high quality

results, good interpersonal skills, and the desire to learn. Over ten

years as a Research and Development Analytical Chemist with laboratory

experience in GLP/GMP testing for pharmaceutical analysis and controlled

substance handling.

Regulatory/Quality Regulations Analytical Development

Support 21 CFR part 210 and 211 Project method

SOP Documentation (cGMP compliance), part development,

IND and NDA Submission 58 (GLP), ISO 9001:2008 validation, data

Documentation (Quality Management processing/review,

Equipment IQ/OQ/PQ System) and FDA technical report

Documentation elements of Process generation, and writing

Validation for Regulatory

Submission

PROFESSIONAL EXPERIENCE

Teva Pharmaceutical Industries Ltd. (CIMA LABS INC.), Brooklyn Park, MN

Research Associate VI 2011 - Present

Research Associate IV 2008 - 2011

Research Associate III 2004 - 2008

Analytical Chemist 2002 - 2004

. Support the Regulatory Affairs department to ensure technical

excellence for product/technology development as well as compliance to

domestic/ international regulatory standards and GMP requirements for

oral pharmaceutical drug products. Preparation of documentation for

regulatory submission: IND (Investigation New Drug Application) and

NDA (New Drug Application) in electronic format (eCTD).

. Provide quality support for process development, project compliance

issues: test plans, procedures, validations, design verification, data

review, design transfer, protocol and report writing for Regulatory

Submission activities.

. Create and close out activities for non-conforming events, CAPA

procedures, out of specification investigations, and Laboratory

Deviations.

. Author and executed IQ/OQ/PQ protocols and reports for various

laboratory equipment and instrumentation.

. Extensive experience writing, reviewing, and enhancing new and

existing documents: analytical test methods, analytical test method

validation protocols, specifications, stability protocols, SOPs,

instrument validation protocols, COAs, and CMC reports.

KARI M. SCHUTZ

3600 Laurel Drive 612-***-****

Deephaven, MN 55391 acfmwu@r.postjobfree.com

PROFESSIONAL EXPERIENCE (Continued)

. Direct and manage small team of technicians assigned to perform all

calibration and performance maintenance duties of all dissolution bath

and UV/Vis spectrophotometers in the Analytical Development

department.

. Approver of all calibration and performance maintenance activities of

all dissolution bath and UV/Vis spectrophotometer instruments in the

Analytical Development department.

. Strong history as a logical and industrious qualified trainer of

various analytical laboratory test equipment and analytical test

procedure techniquies.

. Substantial experience with method development and validation of oral

dosage pharmaceutical product test methods following FDA and ICH

guidelines.

. Conducted thorough quality review and release of analytical data

according to specifications or protocols (including pre-clinical and

clinical data), contributing to the development and improvement of

oral pharmaceutical drug products.

. Proficient in chromatography (HPLC), UV-Vis and FTIR spectroscopy,

dissolution, enzyme activity determinations by colorimetric assay, and

water content analysis by Karl Fischer.

Contract at CIMA LABS INC, Brooklyn Park, MN (Kforce Staffing)

Analytical Chemist April 15- July 15 2002

. Performed analytical chemistry testing for projects in the R&D

Analytical department.

. Provided quality support for proprietary new material and product

development/process validation activities, including product-

development feasibility studies, initial clearance of pharmaceutical

materials and clinical stability programs for drug content, purity,

and drug-release rate.

EDUCATION

Master of Science: Regulatory Affairs for Drugs, Biologics, and Medical

Devices

Northeastern University, College of Professional Studies - Boston,

Massachusetts

Bachelor of Arts: Biology

Bachelor of Arts: Chemistry

St. Catherine University - St. Paul, Minnesota

RELATED SOFTWARE EXPERIENCE

gLIMS(Global Laboratory Information Management System), Maximo (Asset

Management), Microsoft Outlook/Excel/Word/PowerPoint, Adobe Acrobat/Reader,

Waters Empower 2 (Data Acquisition), and TrackWise (Quality Management

System)

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