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Quality Assurance Management

Location:
Tulsa, OK, 74128
Posted:
September 25, 2010

Contact this candidate

Resume:

Lisa Anderson, B.S.

**** *. ***** **** ***** . Tulsa, Oklahoma 74128 . Home: 347-***-****

Mobile: 347-***-**** . e-mail: abkpsy@r.postjobfree.com . Web:

LisaAndersonWeb.com

In Brief

Offering a Bachelor's of Science in Biology / Chemistry and over 8 years

transferrable professional experience, including: quality assurance, web

design, marketing, quality control, document process management, auditing

(internal/external), PHP/MySQL, CSS/XHTML, LIMS Lab Ware, ISO 9001, Novell

GroupWise, Track Wise, Genesis, Password Management, Regulatory Affairs,

New System Evaluation & Calibration.

Laboratory Skills

Gene amplification, PCR and RT-PCR agarose and acrylamide gel

electrophoresis, elution of DNA fragment from gel, designing and random

primer labeling of DNA probes High Performance Liquid Chromatography

(HPLC), Product Formulations, Gas Chromatography (GC), Infrared Mass

Spectrometer (ICP), Fourier transform infrared spectroscopy (FT-IR), Cell

Culture Techniques, Gram Stain, Spectroscopy, Southern Blot, Gel

Electrophoresis, Aseptic Techniques, Lowry Protein Assay, Cell

Fractionation, Enzyme Characterization, DNA Hybridization

Technical Skills

LIMS Lab Ware, ISO 9001, Novell GroupWise, Track Wise, Genesis, Password

Management, LIS (Cerner Classic and Cerner Millennium), Web 2.0, CSS, PHP,

XML, HTML, Adobe Dreamweaver CS4, Adobe Flash CS4, Excel, Access, Word,

Outlook, PowerPoint, Photoshop

Experience

Clinical Lead Dec 2009 - Present

Regional Medical Laboratory Tulsa, Oklahoma

Regional Medical Laboratory is an onsite in-patient laboratory services for

St. John Medical Center as well as out-patient laboratory services for

other hospitals, clinics and physician offices in Northeastern Oklahoma and

Southeast Kansas. Position requires overall clinical supervision in the

laboratory, as well as handling all issues that occur in and out of the

laboratory, as well as being the liaison for any doctors needing service

from the lab. Non - clinical responsibilities include preparing quarterly,

and monthly, quality report and coordinating LIS software updates.

Web Developer / Marketing Specialist Dec 2008 - Dec 2009 Dec 2008 - Dec 2009

Universal Web Solutions Tulsa, Oklahoma

Universal Web Solutions is a web Design Company specializing in affiliate

marketing, SEO & online product marketing. Web Developer responsibilities

include programming and on-going management of several websites; creating

scripts, applications, and forms using PHP/MySQL; and working through

entire development life cycle, from design and architecture, coding and

development, maintenance and troubleshooting, and QA and debugging. Web

design responsibilities include refining graphic design for websites with

Photoshop and InDesign, converting raw images and layouts from a graphic

designer into CSS/XHTML themes. Marketing responsibilities include

planning, development, and implementation of advertising strategies

specific to achieving the goals and objectives of the Marketing Plan in

driving revenue and creating opportunities for cross-marketing with vendors

and partners.

Senior Formulations/R&D Chemist Jun 2007 - Dec 2008

TRC Laboratories Tulsa, Oklahoma

TRC Laboratories formulates and manufactures vitamins and supplements for

private label and contract manufacturing clients worldwide. Laboratory

responsibilities include mixing of compounds (raw materials, vitamins,

minerals, etc) and formulating/reformulating each product to ensure

overages are sufficient to ensure label claim and degradation rate, as well

as design and execute degradation, accelerated, and long-term studies prior

to submitting trial results. Analytical and Micro testing on all lots

manufactured in the warehouse to ensure compliance before shipping to

client. Ensuring all formulations have an acceptable profit margin and cost

target before submitting final formulations to the vice president.

Reformulation of products to compare with supplement facts panel after

analytical results to verify 100% label claim. Maintaining and ensuring

compliance of lab notebooks, log books, and material inventory.

Quality responsibilities include preparing documents for trial and control;

draft production manual, such as Standard Operating Procedures (SOP) in

compliance to cGMP regulations and production documents; and

monitoring/maintaining the RO (reverse osmosis) storage tank and filtration

system. Other responsibilities include the creation, revision, and

approval of laboratory formulations, equipment calibration, and calibration

verification standards. Ensured all laboratory, quality, and production

training compliance (on equipment, work instructions, SOPs); including re-

training due to revisions, update, or corrective/preventative action.

Create costings for all new and improved products, as well as work with

clients on reducing cost for new products.

Regulatory responsibilities include random QA audits (internal and

external) in order to ensure compliance with internal, FDA, NSF, DSHEA,

HACCP, and other regulatory agency. Challenged to achieve compliance with

21 CFR Part 111 (cGMP), 21 CFR Part 11 (electronic records and signatures),

and in the same time keeping productivity high and cost effective for

compliance and regulating efforts for improvement. Implement calibration,

validation, qualification (vendors), and CAPA programs.

Quality Assurance, Project Management Sept 2005 - June 2007

Warroom Document Solutions Boston, Massachusetts

Warroom Document Solutions is an industry leader in single source

litigation services and technology for clients in various fields of

specialty, including pharmaceutical and healthcare. Quality Assurance

responsibilities include tracking and monitoring project document progress,

analysis of raw data reprocessing and comparison, compiling data and

preparing various departmental documents. Other quality responsibilities

include data validation, review, and suitability determination. Project

Management responsibilities include developing project work plans,

marketing material analysis, management of resources and budget for

producing marketing material, and assisting with the concept development

and layout for design of marketing material, and the identification and

development contingency plans and potential product / service exit

strategy.

Stability Laboratory Manager (Quality Department) May 2002 - Sept 2005

Wyeth Pharmaceuticals Andover, Massachusetts

Wyeth is a global leader in prescription pharmaceuticals. Laboratory

management included the direct report responsibility of 9 laboratory techs

- insuring the roles, responsibilities, accountabilities, and performance

measures. Managed lab safety programs and ensured compliance with

regulations. Managed QC inventories, including receipt and issuance of

materials into inventory programs for: cell bank, stability samples,

retention samples, test samples incoming and outgoing and general

inventories. Create timelines and plans to meet established targets.

Quality responsibilities included creation/revision of SOPs, stability

protocols, stability reports, and technical reports, creation, preparation,

and maintenance of real-time stability graphs and charts to monitor

stability trends, and recognized aberrant test results or adverse trends.

Monitored compliance of stability protocols for products against registered

commitments. Responsible for the implementation of new systems,

specifically the development of LIMS Lab Ware for the stability department;

this includes the user requirements and assessments, recommendations and

justifications for design and selection of software applications to meet

sample management, inventory, and stability requirements. Accountable for

the laboratory's regulatory compliance in accordance to 21 CFR 210/211

(cGMP) and 21 CFR 11 (electronic records & signatures).

Education

Bachelor's of Science in Biology / Chemistry

Northeastern State University

Broken Arrow, OK / May 2002

awards & Recognition

National Dean's List (with biography 3 consecutive years) United

States National Mathematics Award Winner

USAA (United States Achievement Academy) Scholarship

Superintendents Honor Roll

President's Honor Roll Dean's Honor Roll



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