EDMONDA S. COOK

Phone: 801-***-****

Email: abobvf@r.postjobfree.com

EDUCATION:

University of Natural Science, Tirana,

M.S. in Industrial Chemistry, 1989

B.S. in Chemistry, 1989

Employment History:

10/10 Present: Quality/Safety Manager, Sports Medicine Research and Testing Laboratory (SMRTL),

Salt Lake City, Utah

8/04 06/09: Research Scientist/Group Leader, Tandem Labs, Salt Lake City, Utah

01/95 02/04: Chemist III, DataChem Laboratory, Salt Lake City, Utah

08/90 06/94: Laboratory Director/Quality Manager, Cement Plant, Tirana, Albania

Employment Experience:

Overview:

Over 20 years experience working in analytical laboratories with a focus on mass spectrometry and the analysis of biological/environmental specimens for pharmaceutical/environmental substances. Worked in a managerial/supervisory role for more than 7 years.

Laboratory experience includes analytical method development/validation and the analysis of biological/environmental specimens using the following analytical instrumentation: mass spectrometry (MS), gas chromatography (GC), liquid chromatography (LC), GC/MS, LC/MS, ICP/MS, ICP T, PE 3100 AAS, GFAA,FLAA and TOC. The analysis involved the isolation of compounds from biological/ environmental specimens using various extraction techniques, maintenance and preparation of instrumentation for sample analysis,data analysis, and reporting of results to clients.

Specific Duties:

Responsibilities as Quality Manager at SMRTL:

• Ensure laboratory compliance with regulatory agency requirements to include, but not limited to,ISO/IEC17025, A2LA, FDA, USADA & WADA.

• Monitor quality control programs and ensure compliance to Quality Policies, Standard Operating

Procedures, WADA/A2LA requirements and ISO/IEC 17025 guidelines.

• Develop and administer technical training programs for the laboratory facility.

• Oversee quality system training of new and current laboratory personnel.

• Ensure quality monitoring in the laboratory is performed at the required frequencies.

• Perform internal audits of all quality system documentation and personnel utilizing the A2LA auditor checklists for general system compliance.

• Manage the laboratory’s document control system and facilitate implementation of policy and procedural updates.

• Facilitate internal/external audits and the deficiency responses.

• Monitor on site inspections conducted by outside agencies. Obtain and maintain ISO and WADA

accreditation and certification for the facility.

• Manage the internal audit program and corrective and preventive action processes.

• Coordinate proficiency testing and Internal Blind QC Program.

• Review Statistical Process Control charts and monitor the LCS program.

• Manage the laboratory equipment calibration and verification program.

• Works closely with the Laboratory Management team.

Responsibilities as Safety Manager at SMRTL include:

• Perform the duty of Health and Safety and Radioactive Safety Officer to ensure laboratory compliance with Occupational Safety and Health Administration (OSHA).

Responsibilities as a Group Leader at Tandem Labs included the following:

• Led a group of laboratory personnel to achieve client commitments and maintain quality requirements.

• Functioned as Project Manager, as required, in their absence.

• Initiated hiring requests, conducted interviews, and made recommendations for hiring.

• Established and monitored performance criteria. Provided routine feedback to team members on

performance. Conducted annual performance appraisals and merit recommendations.

• Established and maintained training objectives.

• Ensured compliance to SOPs and other laboratory policies (safety, security, and personnel).

• Fiscal responsibility included input on operating budget, inventory control, and capital equipment forecast and justification.

• Promoted continuous quality improvement initiatives in all testing and operations.

Responsibilities as a Research Scientist at Tandem Labs included the following:

• Performed extractions (solid phase, liquid liquid, etc.) and LC/MS/MS analysis of small molecule drugs

from various biological matrices in support of pharmaceutical discovery, validation, and sample analysis

studies. Worked according to GLP/FDA guidelines and applicable SOPs for analytical integrity.

• Set up and performed assays on chromatographic and mass spectrometric instrumentation including

HPLC (Shimadzu, Waters) and Sciex Triple Quadrupole mass spectrometers (5000, 4000, 3000, 365,

Ionics EP10+) for LC/MS/MS analysis by Turbo Ion Spray and APCI.

• Scheduled the laboratory instrument use between various projects.

• Performed routine maintenance, trouble shooting, and repairs on advanced instrumentation.

Documented all maintenance, calibrations, and repairs.

• Reviewed analytical data, methods, equipment validations, and study reports for accuracy.

• Ensured that all raw data was properly documented and maintained and projects were conducted in accordance with applicable client and/or bioanalytical division SOPs. Ensured applicable GLP guidelines were followed, reviewed data and final report for accuracy, and responded to QAU project specific inspections.

• Trained other laboratory personnel.

Responsibilities as a Chemist at DataChem Laboratories included the following:

• Performed qualitative and quantitative analysis of air samples (TOC) collected in passivated canisters or

on multi bed carbon adsorbent tubes using GC/MS.

• Prepared and analyzed industrial hygiene/environmental samples (soils, water, wipe and sludge) for inorganic (utilizing ICP, ICP T, PE 3100 AAS, GFAA, and FLAA instrumentations), volatile and semi volatile compounds (GC/MS, HPLC, LC) to meet EPA, OSHA and NIOSH requirements and reported

results within contract required timelines.

• Troubleshoot and perform routine instrument maintenance, cleaned the canisters and conditioned the multi bed sorbent tubes for reuse.

• Reviewed and checked the work of other chemists. Maintained inventory of analytical standards and supplies. Ordered supplies as required.

• Reviewed and Interpreted Data Generated utilizing LIMS system. Conducted Laboratory Departmental Quality Assurance Audits.

• Reported Results for Various Laboratory Proficiency Testing Programs in accordance with EPA, NIOSH and OSHA regulations.

• Managed the Strategic Work Flow for High Profile and STAT Samples

Responsibilities as Laboratory Director/Quality Manager at Tirana Cement Plant included:

• Managed staff members including hiring, training, performance evaluations, and determining

disciplinary actions when necessary.

• Managed the laboratory programs.

• Recommended quality initiatives for production processes.

• Worked with suppliers, customers and internal departments to review material and product

specifications.

• Resolved product and operational quality problems.

• Prepared laboratory annual capital and expense budgets.

• Reviewed reports on compliance, internal/external audits, results of documentation with internal and external quality standards.

• Reviewed and updated new materials and formulas based on operational and customer problems and

suggestions.

• Ensured compliance with department, company policies/procedures, and applicable laws, rules, and regulations.

PUBLICATIONS:

• Capka V, Carter S, Cook E, Nguyen N, Merkle S, “Focus on Method Selectivity: A Mean to Reduce Matrix Effects and Increase Throughput and Ruggedness for Bioanalytical LC/MS/MS Applications”, 55th ASMS Conference on Mass Spectrometry and Applied Topics, Indianapolis, Indiana, June 2007

Meng M, Cook E, Bennett P Chromatographic Improvements and Overcoming Matrix Effects and

•, “Carryover from Previously Validated Nine Analyte LC/MS/MS Assay Using UPLC “, Land`O

Lakes, WI, 2008.

PROFESSIONAL / CIVIC AFFILIATIONS:

•American Association of Pharmaceutical Scientists

•American Society For Mass Spectrometry

•Member Society of Women Engineers

•Member of American Society of Quality

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