Quality Control Technician, Chemist, Lab Technician

Trudi A Myers

***** **** ****** . **********, ** . 80020

720-***-**** . *.*********@*******.***

QuALIFICATIONS

. Strong leadership skills in process development

. Effectiveness in productivity, quality, job knowledge, reliability and

initiative

. A proactive self-starter known for thoroughness & detail in compliance

efforts

. Contract custom manufacturing of APIs and key drug intermediates

. Trained in cGMP compliance systems (pre-clinical to commercial supply)

. Chromatographic separation through purifying crystallization

. Custom isolation and synthesis of taxanes

. Rotary evaporation, lyophillization and distillation of APIs

. Participated FDA audit, document control

Education

Metropolitan State College of Denver

Denver, CO

Bachelor of Chemistry conc. in Criminalistics

Coursework toward meeting the remaining requirements

Front Range Community College

Westminster, CO

Associate of Science

Technical Skills

MS Office (Excel, Word, Access)

SAP,SCADA,LIMS/MES Programs

cGMP Compliance Systems

HPLC/GC analysis

Infrared Instrumentation

Auditing, Document Control

Spectroscopy Instrumentation

Chromatography Processes

Lyophillization Systems

BOD, COD, TSS, pH testing

Professional experience

10/2013 - present Cargill DS&O contract On Assignment

Wichita, KS

Lab Technician II

Successful execution of all quality procedures and any required

laboratory testing ensuring products meet written specifications

Responsible for accurately collecting samples and reporting

analytical results in appropriate company quality systems such as

SAP

Validating analytical results and interpreting data to make

decisions that affect production

Active participation in quality investigations and documentation

of customer issues

Load planning/scheduling of incoming trucks and rail cars in

Adage, MII and TMS as well as quality control testing on all

outgoing orders

6/2012 - 6/2013 Hospira Inc contract Kelly Services

McPherson, KS

Chemist I

Performed qualitative and quantitative analysis utilizing approved

procedures on bulk, in-process and finished pharmaceuticals

Instrumentation utilized for analysis includes: HPLC, GC, Karl

Fisher Apparatus, pH meters

Report writing utilizing Empower 2 software for HPLC/GC assay and

degradation runs for purity

Standard analytical sample and reagent preparation adhering to set

safety techniques and accepted procedures

6/2011 - 5/2012 Microphage contract Resource MFG

Longmont, CO

Manufacturing Associate

Concentrated Phage Suspension and Purification utilizing ACTA HPLC

analysis for quantitative analysis ensuring phage concentration in

trials

Manufactured Microphage products using released documentation

which included reagent formulation, sub assembly and final product

Medical device assembly of MRSA/MSSA Blood Culture Tests in

detection of staphylococcus aureus for antibiotic susceptibility

testing

Ensured compliance to ISO 13485 and FDA cGMPs standards

Supported and performed R&D activities as directed such as gram

staining, lateral flow assays, phage suspension and storage

Ensured laboratory equipment was clean, functional and operating

within defined acceptable ranges set forth in released

documentation

Aseptic processing in clean room environment following cGMP

standards

10/2010 - 12/2010 GlobeImmune contract Aerotek

Louisville, CO

Manufacturing Associate II

Assisted and performed routine procedures following written

instructions in support of manufacturing intermediate, bulk or

final drug product of acceptable quality

Oversaw thaw through harvest of yeast cells operating various size

equipment including mixers, bioreactors, centrifuges and

filtration skids

Worked in a hands-on capacity to operate, troubleshoot and

scale-up equipment including media preparation vessels,

bioreactors, incubators and filtration skids

Reviewed manufacturing and processing equipment documentation and

assisted in their development and revision as necessary

Assisted in investigation/resolution of manufacturing

deviations/non-conformances in a timely manner

Coordinated the contract cleaning of production core following set

procedures for cGMP

7/2010 - 10/2010 Amgen contract Aerotek

Boulder, CO

Manufacturing Process Technician

Performed moderate manufacturing support activities according to

Standard Operating Procedures

Recognized and reported any malfunctions and made any necessary

adjustments to equipment

Analyzed information to select appropriate options from defined

alternatives outlined in SOPs

Applied experience and judgment to assist in making decisions or

resolve issues within defined options or standard protocols

Contributed to fermentation team and closely related teams through

quality and efficiency supporting campaign objectives

7/2006 - 4/2009 Paxis / InB: Hauser Pharmaceutical

Denver, CO

Manufacturing Technician/Associate Chemist

Completed three separate large scale chromatography processes from

the crude product extract in the purification of the

pharmaceutical ingredient (API) Paclitaxel

Purified crystallization of the final product in a climate

controlled manufacturing clean room

Conducted large and small scale custom contract manufacturing of

APIs and key drug intermediates with periodic HPLC analysis

during process

Built, maintained and used large Buchi Rotavap digital rotary

systems and lyophillization systems

Continuously trained and practiced cGMP compliance systems

Enforced quality assurance and quality control plan supported by

continuous training to meet company objectives

Participated in the planning and start-up phases of project

development

Trained in dealing with hazardous materials storage requirements

and handling procedures

3/2005 - 2/2006 Degussa Const. Chemical Co.

Brighton, CO

Quality Control Technician

Tested the quality of all finished products and raw materials

Recommended corrective action if the products and raw materials

did not meet QC specifications

Prepared and modified production process orders using SAP

Calibrated and maintained efficient records on laboratory

equipment

Performed method comparison to select the best analytical method

for certain products

Color matched all finished products and ensured compliance with

packaging standards

2000 - 3/2005 Birko Corporation

Henderson, CO

Quality Control Analyst/Wastewater Chemist

Oversaw the quality of all outgoing products and incoming raw

materials

Performed quality testing which included- titrations on acidic and

alkaline products; refractive index; pH; specific gravity;

chlorine, oxygen and iodine analysis using Karl Fisher Aparatus

Performed infrared spectra - Nicolet's Omnic software

Performed UV\VIS spectra - Cary 50 Bio Spectrophotometer

Conducted the quarterly wastewater analysis as dictated by 40 CFR

403.12 including - BOD, COD, TSS and surfactants

Submitted quarterly wastewater reports to South Adams County Water

and Sanitation District

Seminars & Specialized training

Penn State Conferences & Institutes Continuing Education

. Certificates obtained in BOD, Settleablility and Activated Sludge in

Waste Water

InB: Hauser Pharmaceuticals

. Training in Q7A GMP Guidance for Active Pharmaceutical Ingredients,

Management System & cGMP Compliance

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