Clinical Quality Assurance Auditor - Compliance

SHEILA KWARTENG

**** ************ ***. ****: 419-***-****

New Albany, OH 43054 ******.********@*****.***

Objective A challenging position that demands a strong knowledge base and commitment in quality

assurance/regulatory affairs that will impact professional growth.

Summary

• Strong knowledge of FDA, ICH-GCP, GMP, GLP, 21 CFR Part System, ISO 9001:2000

& European regulations (EMEA)

• Experience with regulatory documentation and IRB submissions for site compliance per

protocols

• In depth understanding of various therapeutic categories and techniques used to assess

disease category

• Extensive understanding of pharmacokinetic/toxicokinetic properties and indications of

various pharmaceutical compounds

• Understand disease pathophysiology and medical terminology used to describe various

disease categories

• Excellent listening and leadership skills

• Strong scientific background and writing techniques

• Skilled contributor in completing tasks where judgment is required in resolving problems

and making recommendations

• Strong communication skills, self starter and team player

• Meets deadlines and works well within tight time constraints

Education Johns Hopkins University, Baltimore, Maryland May 2009

Master of Science Bioscience Regulatory Affairs

University of Toledo, Toledo, Ohio December 2004

Bachelor of Science in Pharmaceutical Sciences with a focus in Pharmacology/Toxicology

Minor in Chemistry

Work Experience

Kendle International, Inc.

Clinical Quality Assurance/Regulatory Affairs Auditor – Compliance

Cincinnati, OH 1/2008 – 4/2009

• Performed internal Systems Audits which focused mainly on clinical mega trial projects

• Conducted regional office audits and external audits (such as for –cause audits,

investigator site audits, Trial Master File audits and vendor audits)

• Developed, reviewed and tracked corrective action plans based on periodic audit finding

review and customer complaints

• Maintained SOPs, forms and templates within 21 CFR Part System

• Identified training issues within Kendle based on compliance trends

• Reviewed, approved and tracked deviations

• Assisted Senior CQA personnel in regulatory authority inspections

• Responded to and resolved issues relating to sponsor audits and regulatory inspections

performed at Kendle under CQA management supervision

• Provided training to Kendle operations or through Kendle College

• Wrote, reviewed or revised Kendle CQA SOPs

• Provided consultancy on quality/regulatory related issues for CQA functions

PharmaForce, Inc.

Quality Assurance/Regulatory Affairs Compliance Auditor

Columbus, Oh 11/2006 – 12/2007

• Performed internal and external audits from a quality systems basis

• Assisted in building a quality system for a start-up company

• Planned, scheduled and conducted QA inspection, audits and reviews to assure adherence

to corporate policies, internal standards and compliance with regulatory requirements

• Ensured quality systems are in compliance with FDA regulations, including systems such

as Quality (deviations, change controls, batch release records), Equipment and Facilities,

Materials, Packaging/Labeling, Production and Laboratories

• Followed up on issues; ensures resolution and closure

• Provided metrics/reports to management as requested

• Reviewed production and analytical documentation accompanying the release of API, bulk

and packaged to ensure conformance to appropriate regulatory requirements

• Maintained current complete and accurate data in the auditing database

• Collaborated with management to determine if sites can continue further business

relationships

• Assisted in compiling, reviewing, and processing regulatory submissions, including

ANDA, annual reports, study protocols and study reports

• Participated in the project/regulatory submission team and provided clear and consistent

regulatory recommendations under an appropriate supervision

Alkermes, Inc.

Quality Assurance Associate

Wilmington, Oh 03/2006 – 11/2006

• Evaluated batch manufacturing and testing records for drug formulations

• Authorized and/or approved written procedures and other documents for production

• Performed quality reviews and area clearances

• Followed up on preventive and corrective actions (CAPA) associated with deviations, lab

investigations, out of specification reports and environmental excursions.

• Knowledge of ISO standards

• Interacted with plant personnel to insure cGMP compliance are being practiced

• Prepared and maintained batch data tables for trend analysis

• Knowledge of aseptic manufacturing techniques

Boehringer Ingelheim - Roxane Laboratories

Quality Control Analyst

Columbus, Ohio 03/2005 – 03/2006

• Assured quality of all raw materials and packaging components used in the manufacturing

and packaging stages of production

• Learned the guidelines that is specific to documentation in the Quality Control Laboratory

that meets with the FDA, DEA, OSHA, ISO and ICH

• Conducted qualitative, quantitative physical and chemical tests such as balances, pH

meters, pipettes, UV Trans, FT-IR, applied force (instron and innova), volumetric

calculations, Residue On Ignition (ROI), Loss On Drying (LOD), Alkalinity or Acidity

tests and Soxhlet apparatus needed in Quality Control Laboratory; report all analytical

findings

• Studied the general guidelines for cGMP, GLP and SOP

Educational Experience

Pharmacology/Toxicology Summer Practicum - 2004

University of Toledo Department of Pharmacology

• Determined thermal effusivity and diffusivity of heat transfer by comparing two particle

size and density that controlled drug delivery and also moderated the permeation rate of a

drug from a reservoir to the body

• Determined different electric signature (or resistance) for different organisms

• Learned the legal processes for drug manufacturing and approval

• Ability to incorporate microbiology and pharmaceutics procedure to get desired results for

drug manufacturing

Pharmacology/Toxicology Laboratory Student Volunteer – 2004

University of Toledo Department of Pharmacology

• Practiced current methods in Pharmacology/Toxicology lab with importance on practical

hands on experience

• Learned the fundamentals for tissue culture, cytotoxity, genotoxicity, pharmacodynamics,

pharmaceutics, toxicokinetics, muscarinic agents, oxidative stress, high throughput

screening, Bradford protein assay, Polymerase Chain Reaction (PCR), ELISA,

electrophoresis

• Ability to recognize and interpret experimental data

Molecular Genetics Laboratory Student Volunteer - 2003

University of Toledo Department of Biology

• Analyzed cloned product using DNA cloning techniques

• Optimized the design of new recombinant DNA molecules

• Identified satellite sequences of different species

• Able to characterize DNA sequencing, in vitro transcription, southern blotting, Colony

Hybridization, Band shift assays and short tandem repeat

• Used Vector NTI, Genomics, and Bioinformatics to aid in the manipulation of DNA

molecules

Omnicare Pharmacy - Pharmacy Intern

Perrysburg, Ohio 12/2001-05/2003

• Formulated and compounded medications

• Answered prospective questions and concerns of nurses and physicians in a professional

manner

• Demonstrated knowledge on a wide variety of products and services available to suit the

unique needs of each customer

Organic Chemistry Laboratory Student Volunteer - 2001

University of Toledo Department of Chemistry

• Learned and practiced the procedure for Organic Chemistry Laboratory Technique

• Learned structure and reactions of Organic compounds using chromatography, catalytic

hydrogenation, distillation, alcohol-dehydration, crystallization and extraction

• Learned the fundamental concepts of fractional distillation by determining the presence of

an unknown and comparing it to IR-Spectrum for compounds in known mixture

Computer Skills

Microsoft Software (Word, Excel, Powerpoint and Access), Macintosh, Adobe Acrobat,

Vector NTI, LIMS, HMI, TrackWise and Oracle

Activities Awards

Treasurer, Alpha Kappa Alpha Sorority Incorporated 2004 – Present

Member, National Pan-Hellenic Council 2004 – Present

Regional Facilitator, Student National Pharmaceutical Association 2001- 2005

Accreditation Council for Pharmaceutical Education (Mastering Your Performance as a QA

Professional) – 1.4 CEU earned - 2006

The University of Toledo College of Pharmacy Dean’s List – 2004

The University of Toledo College of Pharmacy Student Representative Award 2003 & 2004

References Available Upon Request

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