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Medical Device Manager

Location:
Latham, NY
Posted:
August 12, 2015

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Resume:

Jennica Showalter

*** ****** **. ** ************, NY 12154 518-***-**** acq7qm@r.postjobfree.com

www.linkedin.com/in/jennicashowalter/

QUALITY CONTROL MANAGER/ RESEARCH & DEVELOPMENT CHEMIST

Green Belt Certified Research Chemist with expertise developing test methods and managing a laboratory. Experience working in a cGMP analytical chemistry laboratory role in the FDA-regulated medical device industry. Strengths include strong analytical skills, flexibility, the capability to handle multiple projects simultaneously, and the ability to find solutions to business problems. Currently seeking a position that will utilize my educational and interpersonal skills in an environment that provides analytical challenges, emphasizes continuous improvement, and stresses effective communication with a commitment to employee safety and the environment.

Minitab, MicroVU, MS-based applications

Cell / Tissue Culture

Cloning / Southern and Western Plotting

DNA Sequencing

GRAM Staining

Electrophoresis / Polymerase Chain Reaction (PCR)

Histology

Protein Assays

ELISA

Atomic Adsorption

Calorimetry

Distillation and Extraction Techniques

Gas Chromatography (GC)

High Pressure Liquid Chromatography (HPLC)

GC-MS

Titration methods

Infrared and Ultraviolet / Visible Spectroscopy

Chemical Oxygen Demand (COD)

Serial Dilutions

PROFESSIONAL EXPERIENCE

PRIMALOFT, Latham, NY 2014-Current

Global Quality Control Manger

Manage all aspects of daily textile quality control laboratory activities stateside and abroad.

Four direct reports. Three in Latham, NY, one in Xiamen, China.

Performs personnel management functions including time sheet submissions, scheduling of vacations, personnel development, and performance evaluations.

Support corporate engineering efforts with prototype development and validations.

Ensures lab compliance with applicable ASTM, ISO, AATCC Standards and SOPs.

Field, investigate, and mitigate customer and toll manufacturer complaints.

Ensure compliance within Bluesign and Oeko-Tex requirements.

Visit factories throughout the U.S., the Far East, and Europe, to witness manufacturing techniques, and determine efficiency and quality methods. Including record keeping.

COVIDIEN, Argyle, NY 2004-2014

Chemist (2014)

Promoted to lead company coated medical device process transfer activities to Costa Rica.

Wrote all Validation Protocols including IQ, OQ, PQ, and SWV.

Submitted complete, documented, and legible reports of testing. Ensure that data is properly filed and accessible for review in accordance with appropriate SOP’s.

Lead the training process for all associates for the coated medical device.

Lead chemical transfers for all chemicals involved in the coated medical device process and helped with the permit processes.

Recommended and implemented methods to increase the quality of products.

Helped with changing chemical parameters due to water differences.

Managed workload and time to be able perform multiple projects effectively, and ensure all necessary paperwork is completed on a timely basis.

Discuss routinely with transfer engineer the status of assigned programs and potential problems.

Senior Laboratory Technician (2011-2014)

Promoted to manage a manufacturing laboratory with three Manufacturing Associates to test and validate coated medical devices.

Organized data on numerous projects, juggle tasks and problem solve while maintaining a clear sense of priorities and focus.

Reviewed and updated production formulas, quality control test methods and in-process information as required by regulations and product innovation strategy.

Researched suppliers of biological assay kits and identified one to replace a discontinued test methodology which resulted in preventing downtime on the production line and the ability to continue producing the product.

Implemented improvements to production processes using Six Sigma methodologies (DMAIC) which saved $250K+ in one year.

Researched and developed a biological assay using bulk reagents to identify cost saving opportunities.

Provided technical expertise to projects related to process development and improvements.

Authored professional correspondence to corporate offices ensuring full compliance with agency requirements and tight deadlines.

Laboratory Technician (2006-2011)

Implemented and managed testing in R&D, QA, and QC and development and maintenance of product information database to support and facilitate inquiry responses

Designed and set up a Test Laboratory to test coated medical devices.

Trained employees on current and revised procedures

Restructured the laboratory in terms of space allocation and ordered appropriate equipment to perform specified testing techniques.

Calibrated tools and machinery used by Manufacturing Associates in the production of catheters.

COVIDIEN, Hazelwood, MO (2004-2006)

Research & Development Technician (2004-2006)

Worked with a PhD Chemist to develop protocols, procedures and test methods for coated medical devices. Assisted in the development of a test method currently in use for the coated catheters.

Researched coatings and tested them to determine the most durable and medically appropriate coating.

Worked with factor assays for coating verification.

Supported a Microbiologist in the development of a sterilized urine collection apparatus.

Cultivated microorganisms from frozen or lyophilized stocks, utilizing aseptic technique.

Prepared several different types of microbial growth media.

Performed serial dilutions for bacterial plating and counting.

EDUCATION & TRAINING

B.S., Biochemistry, The College of St. Rose, Albany, NY, 2013

A.A.S., Biotechnology, St. Louis Community College, Florissant, MO, 2004

Certificate, Six Sigma Green Belt, 2011



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