Ritu Patel

North Carolina ac1w8a@r.postjobfree.com 313-***-****

https://www.linkedin.com/in/ritu-patel-a9175758

Actively looking for new job opportunities and a carrier change in the field of Process Engineering, New Product Development, and Validation Engineering.

Skills Summary:

BIOPAC, MATLAB, LABVIEW, MINITAB, AUTOCAD, MS Office Suite, TRACK WISE (GEMS), LIMS, ICH guidelines, RA/QA: GLP, GMP, FDA, ISO 14971, ISO 13485, Title 21 CFR 820, IQ, OQ, PQ, HPLC, GC, Educational Summary:

Wayne State University Detroit, MI 05/2015

Master of Science in Biomedical Engineering

U.V. Patel College of Engineering Gujarat, India 05/2013

Bachelor of Technology in Biomedical and Instrumentation Engineering Coursework: Six Sigma(Quality), Biomaterials, Clinical Engineering, Bio-Instrumentation, Sensor, Medical Imaging, Molecular Biology, Orthotics & Prosthetics, Human Physiology, Product Development, Cardiovascular Dynamics Certification: OSHA, Six Sigma Green Belt (Wayne State University) Visa Status: USA Legal Permanent Resident (Green card Holder) Professional Summary:

KBI Biopharma Durham, NC 10/2016- 04/ 2017

Non-Conformance CAPA Investigator

Write quality incident investigations and work with upstream and downstream manufacturing to identify appropriate CAPA.

Drive Documentation Completion of CAPA (Corrective action & preventative action) and CAPA closure

Responsible for reporting department metrics to senior management

Support cGMP-focused continuous improvement activities in the manufacturing areas with problem solving skills

Review and audit maintenance logbook, confidential information and develop recommendation for use by Manufacturing

Performs other duties as assigned

Pfizer Inc. Rocky Mount, NC 07/2015 – 10/2016

Quality Engineer

Write formal investigation to determine root cause & CAPA plan for plant quality issues in accordance with SOPs and various manufacturing departments (Aseptic, Terminally sterilized) on site for process improvements

Utilize 6M’s & 5Why’s methods, fish bone analysis with other investigation tools to review and determine product impact and deviations & Work with internal teams to obtain an in-depth understanding of the product to mitigate Quality deficiencies

Utilize LIMS for tracking laboratory sampling activities & testing of batch manufactured

Provide OJT to newly hired coworker in the group

Knowledge of process & equipment validation protocols & site specific pre-validation studies to support validation activities

Civil Hospital, Ahmedabad Gujarat, India 12/2011 – 01/2012 Clinical Engineering Intern

Updated evaluation report for performance reliability for class I, II, III type devices

Managed the documentation, calibration, troubleshooting of the medical devices

Familiarity with the ER and assisted the team in the ER Academic Work Summary:

Wayne State University 08/2014 – 05/2015

Chronic Pelvic Pain Algometer

Proposed a sensor design for an Algometer that accurately measures CPP

Designed Mask using AutoCAD and fabricated using lithography techniques

Device provides a manual force against intrauterine tissue, fibers and vulvar region via a cannula with a sensor mounted on its tip

Wayne State University 01/2015 – 05/2015

Medicated Sweet Variability

Project was a case study to improve the quality and process using DMAIC approach for a UK food manufacturer

Tools used for improvement were Root cause analysis, Fishbone effect, statistical tools like MINITAB, Scatter Plot, Cp, Cpk, ANOVA

Wayne State University 06/2014 – 08/2014

EMG Signal Recording

System monitoring &recording of EMG signals with BIOPAC software using various weights and position of hands for various subjects of different age groups.

The muscle activity was recorded and analyzed in detail for the peak to peak contraction using BIOPAC software.

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