Quality Assurance Testing

*.*******@*****.***

**** * **** ****** • CHICAGO, ILLINOIS 60645 • PHONE 773-***-****

EDUCATION

University of Illinois at Chicago

Bachelors of Science in Biochemistry, December 2004

LABORATORY SKILLS

Microbiology Techniques

Aseptic techniques

Gel Chromatography

Gram Staining & Microbial ID

Environmental Monitoring

Bacterial Endotoxin Test Cell/Molecular Biology Techniques

PCR, qPCR, RT-PCR

Flow Cytometry, ELISA , FISH, RNAi, Immunohistochemistry

Northern, Western, Southern Blotting techniques Wet, inorganic, organic, analytical, physical chemistry

Water Chemistry, TOC, Conductivity & pH

GC, Headspace GC, HPLC , FTIR, Polorimitery (Optical Rotations)

Manual & Automatic titrators, Karl Fisher

Yeast Enzyme kinetics

EXPERIENCE

09/2011– 11/2011 Midwest BioResearch - CRO Skokie, IL

Sample Handling Supervisor

Maintain working knowledge of FDA 21 CFR 11 & 58 & 40 CFR 792, EPA 40CFR 160, guidance’s for Good Laboratory Practices (GLP) and compliance. Manages daily operation of sample handling group including receipt, processing (login/verification), storage, tracking and disposition, of all samples/test articles for Midwest BioResearch (MBR) customers utilizing Excel and/or Laboratory Information Management System (LIMS) respond to client & QA investigation’s or questions, write deviations, instrument monitor, and perform lab audit lab tours.

Supervises team of Sample Handler(s).

Manages sample/ test article shipments (incoming and outgoing) for MBR customers including prioritization and processing in support of genetic toxicology, drug deposition & toxicology, protein bioanalysis (ELISA), chromotragraphy.

Maintains and updates Sample Handling group/LIMS processes, as necessary, to align with company initiatives, and expand use of LIMS, implementation of e Notebook system within department.

Controlled substances monitor and dispenser for research purposes.

Make recommendations for instruments and process needs.

Perform laboratory tour, respond professionally to FDA, internal & client audit questions and quality assurance findings.

Author and or communicate quality system documents, Out of tolerance (OOT), deviations, and QA investigations.

Recommend and implement quality improvements within department.

Make recommendations for instruments and process needs.

Review of department logs and data trending.

Oversees customer protocol entry into LIMS.

Maintains sample-tracking spreadsheets for all bioanalytical studies at MBR.

Maintains tracking spreadsheets for all test articles, including controlled substances, received at MBR.

Develop and maintain sample storage and tracking system for storage units (refrigerators, freezers, room temperature) within the sample-handling group.

Trains Midwest BioResearch employees on LIMS, controlled substances and sample handling processes.

Authors and reviews SOPs.

Acts as instrument monitor for MBR equipment.

Maintains/reviews instrument logbooks and reviews laboratory processes for GLP compliance.

Interacts with groups within and external to function (e.g. sponsor, testing facilities, clinical sites, central labs, other CROs).

Effectively works in a team environment.

Complies with applicable SOPs, policies, procedures, governmental (GLP) and safety regulations.

02/2007– 09/2011 Ferro Pfanstiehl Laboratories Waukegan, IL

Microbiologist /QA Specialist

Maintains working knowledge of FDA ICH Q7A, USP/NF, and 21CFR 210 & 211 guidance’s for good manufacturing practices (GMP) and compliance. Performs both QC & QA job functions such as environmental monitoring, water system monitoring, bacterial endotoxin testing, raw material & finished product testing, validations, writing SOP’s, CAPAs, OOSs, OOTs, internal auditing, supplier assessment and decommissioning, batch record review, address QA/client/FDA questions & concerns, and data entry/review in Excel databases.

Quality assurance internal/external auditor with experience in supplier quality audits, and product audits.

Develop and maintain quality audit plans and prioritize audit focus points, conduct reviews of technical documentation, identify risks, determine actions, prepare final audit report, and communicate findings, including compliance risk.

Create audit-opening meetings and closeout meets using Power point presentations.

Review and evaluate internal/external audit responses against current industry standards, regulations, and guidelines to assure compliance. Participate in the remediation efforts of client & FDA responses when necessary. Drive closure of Corrective and Preventative Action (CAPA)’s to ensure implementation, compliance and continuing efficacy as well as gap assessment audits.

Assist/lead in API product and quality control investigations such as non-conformance of materials, instrument out of tolerance, product out of specification, to identify corrective actions, and monitor corrective action effectiveness in a cross-functional setting within a (CAPA) system.

Participate in the handling of customer complaints and product release.

Author and or communicate quality system documents, SOP’s, OOT, OOS, deviations, and CAPA investigations.

Support fine chemical drug reagent manufacturing, process engineering and engineering through participation in validation of product IQ/OQ/PQ support reports, process controls, critical systems, cleaning processes, product sterilization processes, environmental monitoring validation, USP water validations, supplied nitrogen validations, compressed gas validations and other development and testing.

Familiarity with Ferro Pfanstiehl Laboratories (FPL) process & cleaning, batch records, cleaning procedures and manufacturing & sterilization methods of fine chemicals HPLE’s & potent compounds.

Experienced in authoring & reviewing technical reports such as the USP/NF and ISO regulations, product impact report for bioburden excursions and standard operating procedures (SOP’S) with adherence to quality system guidelines.

Respond professionally to internal & client audit questions and quality assurance findings.

Data trending & statistical analysis of environmental monitoring program, USP purified water system, bacterial endotoxin testing, or LAL, and water chemistry samples using Microsoft Word, Excel, Power point and Pivot tables.

Develop Excel databases and Pivot tables for cleanroom manufacturing suites to address reoccurring incidents and or CAPA’s.

Statistical process control chart development in MS Excel.

Maintain/communicate training records on site SOP’s, cGMP, and EHS training using document control system.

Budget management, maintain calibration schedule of equipment and supply chain management between laboratory and vendors.

Manage, train & work effectively with colleagues from a variety of backgrounds, and with different departments (QA, QC, Engineering, Maintenance and Manufacturing), and levels/areas of training.

Recommend and implement quality improvements within microbiology lab.

Timeline development of laboratory testing for finished products, and biological testing which support manufacturing.

Participate in Environmental Health & Safety (EHS) safety program and initiatives.

Make recommendations for instruments and process needs.

Author, perform, develop processes, and test method validation for testing requirements of USP & FDA guidelines, for consumables and new finished products.

Review of laboratory results, notebooks, and maintain data trending of environmental monitoring, water bioburden, water chemistry, and growth promotion testing.

Bacterial identification of samples, staining techniques, biochemical testing, and microbial identification.

Perform environmental monitoring and bioburden testing of clean rooms, air, water, and surfaces using a MetOne or Climet particulate counter, SAS air samplers, dew point testing, and room differential pressure monitoring.

Maintain and monitor the USP purified water system for conditions leading to excursions in total organic carbon (TOC), conductivity, bioburden using membrane filtration to detect bioburden, TOC analyzer, water conductivity meter and Coliform testing.

Perform bacterial endotoxin testing or LAL of USP purified water, in-process samples, and finished products.

02/2007– 09/2011 Ferro Pfanstiehl Laboratories Waukegan, IL

QC Chemist

Testing of raw materials, in-process samples, finished products, stability samples, and cleaning samples in support of release of materials.

Review analytical data for compliance with SOP’s, cGMP, and ICH guidelines.

Assist in training of other analysis in the performance of testing.

Review and edit SOP’s as necessary.

Perform identification using various wet chemistry, spectroscopic techniques using UV/VIS, FTIR, polorimitery, chromatographic techniques as TLC, GC, and Headspace GC, testing for TOC, use of manual and automatic titrators such as Karl Fisher, and pH testing.

Data trending in spreadsheets, maintain analytical equipment, and maintain accurate, clear, and concise laboratory documentation.

01/2005 – 02/2007 Hospira Inc. North Chicago, IL

Associate Microbiologist - (Microbial ID Lab)

QC Laboratory and field-testing of microbiology: Environmental monitoring of clean areas, WFI water system maintenance and bio-burden testing and microbial ID using FAME GC system. Vitek, microbial culturing, and repot writing of OOS.

Comply with FDA & EU regulated aseptic requirements, Hospira Inc. BOP’s, & cGMP’s.

Categorization & identification of microbes via Gas Chromatography.

Categorization & identification of microbes via Vitek and other offline tests to find separation between organisms.

Harvesting, culturing, and streaking using aseptic techniques and gram staining.

Writing identification and product impact report based on categorization & identification of microbes for investigators.

Participate in engineering validation studies for sterilization/ lyophilizing methods, micro-challenge in sterilizers and lyophilizers with biological indicators.

Maintain laboratory equipment and stock of laboratory reagents.

01/2005 – 02/2007 Hospira Inc. North Chicago, IL

Associate Microbiologist - (Environmental Monitoring)

Product quality assurance, cGMP, aseptic techniques, start-up of manufacturing site, media fills.

Environmental monitoring of a highly FDA & EU regulated aseptic & non-aseptic environment; as surfaces, air, gases, water, bio-burden, bacterial culturing & isolation, validation of equipment, process test samples using LIMS database, use & maintain lab equipment (Climet, SMA, SAS).

01/2005 – 02/2007 Hospira Inc. North Chicago, IL

Associate Microbiologist - (Water Lab)

Aseptically perform routine sampling of production water & detergents imperative to product release of FDA & EU regulated environment. Sampling of WFI, purified, distilled, deionized, aerobic microbial count (AMC), tap, softened, autoclaved water, steam, & detergents.

Sampling of sites for particulate, aerobes, anaerobes, thermopiles, endotoxin, water chemistry (color clarity/odor, conductivity, heavy metals, nitrates, & total organic carbon (TOC) & pre-sterility.

Perform microbiological filter testing of production waters & coliform testing of portable & fresh water samples.

Research Experience

08/2004 – 12/2004 University of Illinois at Chicago (UIC) Dept. of Microbiology & Immunology Chicago, IL

Lab Aide

Perform bench work & basic lab duties: cleaned lab, washed glassware, prepared solutions, ordered supplies & stock.

Assisted PhD. students with their experiments: PCR, transformation, Gel Electrophoresis, spectrophoto measurement of DNA, RNA & Protein concentration, cesium chloride large preparatory, restriction digest & performed pure culture techniques.

2002-2004 Rush University Medical Center Chicago, IL

Volunteer - Research apprentice

Perform lab work, including the fallowing: PCR, Gel Electrophoresis, DNA & RNA purification, ELISA, Concentration of virus from supernatant, and processing of patient samples from blood lab.

Train new volunteers or residents in research laboratory methods.

Shadow MD. during rotations of Cancer patients.

Commendation given in Published Abstracts in American Society of Hematology (ASH)

Reeddy PL, Shetty V, Alvi S, et al: Sequencing of the Entire Mitochondrial DNA in the Bone Marrow Cells of

Patients with Myelodysplastic Syndromes (MDS) for Detection of Mutations (Abstract 3396). Blood 102:442a,

2003.

Shetty V, Verspoor F, Nguyen H, et al: Effect of proteasome inhibition by bortezomib on tumor necrosis

factor alpha (TNF-α) and apoptosis in patients with myelodysplastic Syndromes (MDS) (Abstract 1534). Blood

102:442a, 2003.

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