Medical Safety Officer

Kaitlin Shea

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

Address: **** *** ****** *. *** 340 Arlington, VA 22203 Phone: 540-***-****

EDUCATION Bachelor of Science, University of Mary Washington, Fredericksburg, Virginia (May 2008)

Major: Biology, Honors

WORK BioReliance, Rockville, MD (Winter 2012- Current)

EXPERIENCE Team Lead - Associate Scientist III

Provide genetic analysis of clinical samples (Phase I-III) and preclinical discovery related

projects to Pharma companies.

• Perform Illumina Array assays

• Responsible for managing and consulting clients in PGx-related studies

• Back up Study Director. Responsible for all projects to follow proper GLP compliance. Schedule

multiple custom studies, ensuring smooth communication with project managers and clients for

multiple assays

• Upon lab completion of projects, I conduct data analysis and provide final report summaries of all

projects for submission to clients. Also ensure all data accuracy, quality, and technical issues are solved

• Work closely with current study director to exceed clients’ demands and guarantee on-time delivery

• Execute the weekly ordering and inventory tracking for Clinical Genomics

• Quickly manage any events or deviations observed by QA in a timely manner

• Perform IOPQ validations for laboratory equipment and computer equipment (IQ, OQ, PQ and 21

CFR Part 11 compliance)

• Conducted assay validations following applicable ICH, GMP and GLP guidelines.

• Provide continual improvements to the laboratory workflow upon growth of department by providing

scientific guidance in the areas of analytical instrumentation, automation technology, genomics and

biomarkers

• Optimized and validated PicoGreen quantitation. Also qualified the DNA Methylation assay

• Work closely with bioinformatics personnel to develop internal software programs and databases to

increase productivity. Also work with the bioinformatics team to review and approve data QC and

transfer to client in a timely fashion

• Led the implementation of Clinical Genomics HT-LIMS

• Write new SOP’s and revise existing SOP’s

• Make all Batch Records for laboratory procedures

• Conduct interviews during hiring processes

• Successfully host clients for technical and quality audits. Additionally, assist in the hosting of quality

audits by regulators such as the FDA

BioReliance, Rockville, MD (Fall 2010 - Winter 2012)

Associate Scientist II

Provided genetic analysis of clinical samples (Phase I-III) and preclinical discovery related

projects to Pharma companies.

• Performed Illumina Array assays

• Responsible for managing and consulting clients in PGx-related studies

• Collaborated with Study Director to establish the development and organization of a new lab within

BioReliance.

• Scheduled multiple custom studies, ensured smooth communication w ith project managers and clients for

multiple assays. Work closely with current study director to exceed clients’ demands and guarantee on-time

delivery

• Performed assay optimizations for both Goldengate SNP genotyping and ADME assays

• Led the design and validation of Clinical Genomics HT-LIMS

• Drafted and executed all batch records and SOPs for a new lab

• Performed IOPQ validations for laboratory equipment and computer equipment (IQ, OQ, PQ and 21 CFR

Part 11 compliance)

• Conducted assay validations following applicable ICH, GMP and GLP guidelines

• Executed the weekly ordering and inventory tracking for Clinical Genomics

• Wrote program scripts for automation

• Trained all staff members in Clinical assays and laboratory protocols

• Performed the scheduling of internal and external projects

• Conducted interviews during hiring processes

Kaitlin Shea

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

Address: 4401 4th Street N. Apt 340 Arlington, VA 22203 Phone: 540-***-****

WORK BioReliance, Rockville, MD (Summer 2008- Fall 2010)

EXPERIENCE Associate Scientist I

Cont. Provided biosafety testing for client samples through means of PCR and Q -PCR

• Performed gel endpoint PCR to detect the presence of viral genome in test articles

• Conducted assigned test procedures independently

• Broad working knowledge of lab policies assays and protocols

• Revised existing assay SOPs and peer reviewed assay batch records

• Performed data analysis using SDS software

• Trained new staff members

• Maintained thoroughly detailed records all while complying with cGMP/ GLP regulations

• Contribute ideas and suggestions to improve protocols, proces ses and techniques

• Department Safety Officer

Mary Washington Hospital, Fredericksburg, VA (Summer 2006 – Summer 2008)

Companion Aide

• Provided one-on-one general care and observation for patients suffering from Alzheimer’s disease, strokes,

dementia and other general aging difficulties in a hospital setting

• Assisted the CNA and RN in patient related tasks

• Informed RN of any patient related complications and concerns

• Kept records of patient related information

Lloyd F. Moss Free Clinic, Fredericksburg, VA (Summer 2006 – Winter 2007)

Volunteer Medical Screener

• Performed one-on-one consultations with patients unable to afford medical insurance

• Trained over 10 new volunteer medical screeners

• Took patient’s vital signs, recorded medical history and reason for visit

• Presented the patient’s vital signs and medical history directly to attending physicians

LABORATORY TECHNIQUES:

• Goldengate SNP genotyping • RNA Extraction (Qiagen • Experimental Design

• ADME genotyping RNeasy Kit) • cGMP/ GLP Certified

• DNA Methylation Assay • Assay Development • Pipetting

• Bisulfite Treatment of DNA • Sterile Technique • Serial Dilutions of Stock

• PCR • DNA Normalization Cultures

• Qualitative PCR • QIAgility Programming • Data Display and Analysis

• Quantitative PCR • epMotion 5075 and 5070 • Use of LabWare LIMS

• Gel Electrophoresis Programming • TOPO Cloning

• DNA Extraction (Qiagen Blood • DNA/ RNA Quantitation (FL • GMP/GLP certified

Kit/ Invitrogen Easy DNA Kit) and ABS)

INSTRUMENTATION & SOFTWARE:

• Illumina BeadXpress • Nanodrop • SDS 2.4 Software

• ABI 9700 PCR System • SpectraMax micro- plate readers • Electrophoresis of nucleic

• Agilent BioAnalyzer (Plus/ M2/ M5) acids and proteins

• ABI Prism Sequence Detection • Kodak Gel Logic 100 Imaging • VeraReport

System 7900 System • SoftMax Pro

• QIAgility • Centrifugation • GenomeStudio

• QIAsymphony • UV/FL spectrophotometer • Rainin Liquidators

• Troemner • epMotion 5075 and 5070

PROFESSIONAL • Knowledge of both Macintosh and Windows operating systems

SKILLS • Proficient in Microsoft Office X

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