Medical Device Quality Control

Jason Lichtenstein

Loveland, CO *****

970-***-**** . ************.*****@*****.***

Analytical Chemist

Detail-oriented and analytical with history of success contributing to

rapid productivity growth of ISO- and ASTM-certified laboratory.

Proven track record of accuracy and precision within fast-paced production

and R&D environments requiring superb chemical testing, experimental

design, and hazardous materials handling capabilities. Highly focused and

resourceful in facilitating deadline-driven operations; promote a positive

collaborative workplace by communicating effectively across organizational

levels and with external project stakeholders. Research and technical

expertise includes...

Research Organic and Inorganic Chemistry, Molecular Genetics, Cell

Fields: Biology

Methodologies: Wet Chemistry, cGLP /cGMP, sterile techniques, tensile

testing, micropocket analysis, gel electrophoresis, cell

culture, cleanability/sterilizability testing, bioburden

testing, sterility testing, audit preparation, validation

testing, hazardous materials/waste handling

Software: MS Office Suite (Word, Excel, Access, Outlook) on Windows

Equipment: UV/Vis, CVS, HPLC, PCR, SEM,, FTIR, mass spectroscopy,

Micro-pipettes, incubation ovens

Experience Highlights

Custom Microwave Inc., Longmont, CO

Chemical Analyst, 2/2012 - Present

Lab Environment: ISO9001:2000 and AS9100 Rev C Certified

Perform and optimize daily chemical testing assays at state-of-the-art

electroforming and plating lab in support of production and R&D cycles of

aerospace communication hardware. Prepare and analyze solutions and

samples, perform statistical analysis of solution and metal components,

provide coupon analysis, and initiate quality control checks; troubleshoot

and resolve technical issues. Facilitate quantitative and qualitative

analysis of tank solutions. Define standard operating procedures and

create and convey lab work instructions, ensuring adherence of all testing

activities with established quality standards and specifications. Keep

chemical solutions current; inventory, order, and document chemical and

analytical supplies. Ship samples and solutions for outside analysis;

review test data from off-site analyses on a monthly basis. Provide

advanced support to R&D team in new process development and quality

assurance issue resolution.

Selected Contributions:

. Helped plan, prepare and execute a 200% growth for lab within 3

years, doubling lab size and production.

. Rescued thousands of dollars in chemical and consumable overhead by

streamlining processes and restructuring procedures.

. Served on Emergency Response Team (2013, 2014), Health and Safety

Team (2014), and Team for Intelligent Growth (2013).

. Trained and mentored lab technicians and chemical analysts.

. Contributed to internal preparation for ASTM, ISO, OSHA, and EPA

audits as well as participating actively in NADCAP certification

process.

. Maintained yearly OSHA HAZWOPER and RCRA designations.

. Stepped up to perform ad hoc special R&D tasks.

Covidien Surgical Solutions (through Kelley Scientific Services), Boulder,

CO

Microbiologist, 6/2011 - 10/2011

In contract role with Microbiology lab of a global health care products

developer, meticulously performed bio-burden, sterility, sterilizability,

and cleanability testing. Prepared media; conducted environmental surface

and air monitoring of controlled environments. Utilized FTIR for silicone

analysis.

Selected Contributions:

. Provided key support during lab preparations for FDA and internal

audits.

RMC Pharmaceutical Solutions (through Kelley Scientific Services),

Longmont, CO

Lab Technician, 2/2011

In month-long contract assignment, conducted FDA testing of medical device

utilizing micro-pipette, incubation oven, and GxP techniques.

Selected Contribution:

. Successfully performed and documented bio-hazardous testing

procedures, key to the timely FDA approval of a medical device now

used in hospitals nationwide.

Education & Credentials

Colorado State University, Fort Collins, CO

Bachelor of Science in Biology (Emphasis: Biological Sciences), 2010

Certifications

. OSHA HAZWOPER (yearly since 2012)

. RCRA (2012, 2014)

. DOT Hazardous Materials (2014)

Affiliation

. Electrochemical Society Member (ongoing)

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