Quality Assurance Data

Jacquelyn Wilkie

617-***-**** ** Vinton Street

**********@*****.*** Melrose, MA 02176

Objective

Seeking a challenging position in an R&D or QA/QC lab where my experience in analytical techniques will be

utilized.

Qualification Highlights

Six years of laboratory experience, two in a med device / pharma GMP environment. As one of only a

few chemists in a contract laboratory, the projects I work on vary greatly. This has allowed me to

develop a broad base of knowledge and hands-on experience for many types of analyses, including

stability sample management and developing methods and procedures. I am responsible for projects

from inception to completion, instrument maintenance, troubleshooting, performance verification,

internal calibration runs, preparation of samples including extraction, data analysis, and generating

reports for clients.

I have experience in laboratory techniques commonly used in the analysis of pharmaceutical products,

especially investigation of degradants and impurities of drug compounds using various instruments as

well as wet chemistry. I am responsible for conducting all biological assays such as ELISA and EIA Assay,

as well as Slot Blot and other protein assays. My duties also include writing and revising Standard

Operating Procedures. I implement and maintain GMP of laboratory records, procedures, and systems.

Experience

Analytical Chemist – Millennium Research Laboratories, Inc. Woburn, MA, September

• My current job description covers the rolls of QA Manager and QC Analyst. I am the supervisor for

laboratory technicians. I quickly came up to speed in this lab and became the go-to person for

both quality assurance and analytical testing responsibilities.

• Responsible for conducting all biological assays such as ELISA and EIA Assay, as well as Slot Blot

and other protein assays. This includes performing the assay, operation of plate readers and

washers, and analysis and interpretation of the data collected.

• Responsible for writing new Standard Operating Procedures (SOP’s) and revision and rewriting of

GMP methods to ensure compliance. I have developed QA protocols including handling and

reporting of data, and a CAPA (Corrective Action and Preventative Action) System.

• I am skilled in analyses using USP methods. I regularly test samples using HPLC, Gas

Chromatography, Karl-Fischer coulometer, UV/VIS spectrophotometer, Total Organic Carbon

analysis, viscometer, conductivity meter, tensile testing, wet chemistry, column chromatography,

R&D stability testing, and method development and validation. I am also responsible for

calibration, maintenance and troubleshooting a variety of standard laboratory equipment.

• I have excellent communication skills, which I honed through various presentations at professional

conferences as well as written reports. In my current position, I routinely communicate results

and prepare project reports for clients. I have extensive experience preparing and presenting data

by using programs such as R Statistics, PowerPoint, Word, and Excel.

Highlights during which I earned a Masters in Marine Biology at the College of Charleston, Charleston, SC

• Thesis project in community assessment of inshore fishes which consisted of year round sampling.

Extensive statistical analysis of community composition in order to determine effects of chronic beach

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re-nourishment and climate change.

Interpreted, summarized, and communicated results via state technical reports, thesis, and various

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presentations.

Experience working with large data sets and constructing statistical designs.

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Graduate course work in animal physiology, oceanography, biometry, physiology, ichthyology, fisheries,

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invasive species, and ecology.

Applied for and received the College of Charleston Graduate Student Presentation Grant for presenting

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my research at an international professional conference (2008).

Graduate Assistantship with South Carolina Department of Natural Resources (SCDNR) Cooperative

Fisheries Research Program under Prof. David Whitaker

• Having an eye for detail, I entered volumes of raw data and verified accuracy for a historic study. I

contacted observers to address inconsistencies and solve data recording problems.

• W as a DNR representative at state sponsored tagging events to improve communication and

outreach with local fishermen

Lead a seminar to instruct Charleston County Park employees on how to properly identify local

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fish species.

Teaching Assistantship with College of Charleston, teaching college level biology labs

• Taught four semesters of the course ‘Evolution, Form, and Function of Organisms’. This course

provided science majors an introduction to laboratory practices.

• Each semester I was the primary instructor for three labs, and a teacher assistant for the corresponding

lecture.

Graduate Assistantship at the College of Charleston’s Grice Marine Laboratory, Charleston, SC

• Designed all program advertising initiatives including posters, fliers, presentations, and list-serve notices.

• Assisted in interviews of potential faculty candidates and potential graduate students.

• Balanced laboratory budget and expense accounts.

Other Industrial experience

Laboratory technician at Surgical Sealants Inc. in Woburn, MA

• Responsibilities included assisting research scientists in product development, testing product

integrity, as well as regularly working in class 10,000 clean room and class 100 laminar flow hood.

Professional Skills

Instrumentation

• HPLC (including SEC-HPLC, RP-HPLC as well as use of RID, DAD, and ELSD), Gas Chromatography

(GC-FID and Headspace), Karl-Fischer coulometer, UV/VIS spectrophotometer, FT-IR, conductivity

meter, viscometer, tensile testing, R&D stability testing, Total Organic Carbon analysis, and

method development and validation.

Statistical skills

• Analyses with which I am comfortable include, but are not limited to, simple and multiple

ANOVAs, linear and multiple regressions, Kruskal Wallace, Kendal’s Tau, Wilcoxon test,

bootstrapping, jackknifing, Bonferroni corrections, paired and students’ t-tests, analyzing

preliminary results to determine effort necessary for adequate sampling, various statistical tests

used to determine violation of statistical assumptions.

Computer Knowledge

• Extensive experience working with Cirrus GPC Software, Chemstation, R Statistical Programming,

DataPro, and Softmax Software, Microsoft Word, Excel, PowerPoint, and Adobe.

Education

M.S. Marine Biology, 2010. GPA: 3.82

College of Charleston, Charleston, SC

Four decades of change: the surf zone macrofauna at Folly Beach, South Carolina

• My thesis involved method design and implementation of a sampling program in which data was

collected for over 1700 fish representing 28 species. I conducted all statistical analyses on the

collected data and compared abundance and community composition to that of a historic study.

I maintained and routinely audited data records for all collections conducted during my thesis study.

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I presented my findings through various presentations at professional conferences, both

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international and local. I also communicated results via various written reports including state

technical reports.

B.S. Biology (Minor in Chemistry) 2005. GPA: 3.49

University of North Carolina, Wilmington, NC

• Direct Individual Study in column chromatography of micelles

• Direct Individual Study in experimental design and statistical analysis

• Presidential Excellence Award for Outstanding Academic achievement

• Field course in method development and sampling techniques in Curacao, N.A.

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