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Manager Quality

Location:
Portland, Oregon, United States
Salary:
80,000
Posted:
December 13, 2018

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Resume:

Qualification Summary

Quality Manager adept at ensuring high standards on incoming raw materials, outgoing finished products, manufacturing, and packaging of dietary supplements. Utilizes lean quality management systems to increase workflow and productivity. A team leader and motivated industry professional with an extensive background in technologies, testing, and best practice development.

Professional Experience

Quality Control and Assurance Manager 2017 – 2018

Highland Laboratories, Mt. Angel, OR

Managed a team of 4 direct reports including hiring, training, and performance reviews.

Lead & Resolved all OOC/OOS incident investigations by defining root cause and implementing process changes in the factory to improve production yield and robustness.

Developed 20+ new QC methods to reduce 3rd party testing by 15% ($30k/yr) and enable new product opportunities using HPLC-UV/VIS and LC-MS/MS analysis, microbial contamination testing, FTIR validation, ICP-MS heavy metal and mineral testing.

Increased lab capacity by 300% while maintaining turn-around analysis time for 200 raw materials and 100/month finished products.

Procured, installed, and developed methods for new LC-MS/MS and rotovap equipment.

Rolled out new QMS system to ease sample tracking and consolidate lab results.

Participated in audits conducted for FDA and GMP certifications.

Graduate Research Assistant 2012 – 2017

University of Illinois at Chicago (UIC), Chicago, IL

Department of Medicinal Chemistry and Pharmacognosy

Determined tissue distribution and pharmacokinetics of the cancer treatment drug, Sorafenib in rat and rabbit tissue by detecting psychosine using UPLC-MS/MS.

Analyzed the quality and content of valerenic acid in common over-the-counter valerian root extracts using thin layer chromatography and HPLC-MS/MS.

Extracted and separated plant compounds by isolating agonist/antagonists of the RXRα receptor using magnetic bead affinity selection screening.

Developed new methods using liquid, solid-phase, and liquid-liquid extraction on an UPLC-MS/MS specifically to quantify bisphenol-A, bisphenol-A-glucuronide, brodifacoum, and four critical compounds found in the kratom plant (Mitragyna speciosa).

Trained visiting scientists and students on operation of LC-MS systems.

Maintained five mass spectrometers, including Shimadzu 8040 triple quadrupole, Shimadzu 8050 triple quadrupole, Shimadzu 8060 triple quadrupole, Shimadzu IT-TOF, and Waters Q-TOF, and LC systems.

CMP Pad Quality Lab Technician 2010 – 2012

Cabot Microelectronics, Aurora, IL

Conducted material testing of polyurethane foams including thickness, shore A hardness, tensile strength, surface micro-roughness, specific gravity, SEM, and color detection.

Developed a Certified Test Method for measuring pore sizes using a JOEL SEM.

Investigated customer complaints by analyzing failed product, determining root cause, suggesting internal corrective actions, and composing final reports.

Analyzed new materials and provided feedback for R&D product development teams.

Improved the tolerances and reproducibility of Mettler gauge thickness measurements during six sigma greenbelt project and assisted on several black belt projects with senior scientists.

Performed biannual GR&R on lab equipment and other statistical analyses using minitab and attended monthly trend review meetings to ensure processes remained within specifications.

Completed Six Sigma Green Belt Certification.

Hine’s Emerald Dragonfly Project Field Researcher and Supervisor 2009 – 2010

University of South Dakota, Vermilion, SD

Supervised a small group of 3-6 researchers in the field. Summarized findings, communicated with the primary investigator, and organized the team’s daily activities.

Extracted the larva of the endangered Hine’s Emerald dragonfly to perform DNA testing, collect eggs, and allow maturation.

Observed and identified adult dragonflies and their flight patterns to determine high traffic areas of concern to the endangered species.

Tested water quality of streamlets and burrows in habitats by measuring temperature, flow rates, pH, dissolved oxygen, and turbidity.

Education

Ph.D. in Pharmacognosy 2017

University of Illinois at Chicago (UIC), Chicago, IL

Mentor: Richard B. van Breemen, PhD

Bachelor of Science, Double Major in Biochemistry & Zoology 2009

Minnesota State University, Mankato, MN

Awards and Certifications

W.E. van Doren Scholar, University of Illinois at Chicago, 2016

Six Sigma Green Belt, Cabot Microelectronics, 2011

Published with 3 first author publications and a total of 10 peer reviewed articles



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