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Quality Control

Location:
Chicago, IL
Posted:
October 10, 2019

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Resume:

Charulata Patel

Email: *********@*****.***

**** * ******** *******, *******, IL- 60610,

734-***-****

https://www.linkedin.com/in/charulata-patel-93702b11a

Quality Driven Professional with expertise in Quality Control and Inventory Management. A skilled and proficient worker looking for opportunities inthe Medical Devices, Pharmaceutical, Nutraceutical, Electronics (ISO), Auto Part Manufacturing and Plastic Industry.

SKILLS

QUALITY CONTROL/QUALITY ASSURANCE

ISO DOCUMENTATION

GD&T

UNDERSTANDING SCHEMATICS/BLUEPRINTS

FIRST ARTICLE/INPROCESS INSPECTION

INVENTORY MANAGEMENT

AUDIT

STABILITY SAMPLE MANAGEMENT

GMP, FDA AND DEA GUIDELINES

FIELD ASSURANCE - TECHNICAL EVALUATION, TECHNICAL WRITING

SOP, WORK INSTRUCTIONS & PROTOCOL

TIME MANAGEMENT, COMMUNICATION

MICROSOFT OFFICE,

MASTER CONTROL, TRACKWISE, iSTABILITY, DYNAMICS AX

PROFESSIONAL EXPERIENCE

Field Assurance Technician, Quality Assurance February 2019 – July 2019

Becton Dickinson and Company, Tempe, AZ

●Responsible for Receive returned complaint samples in Trackwise (Online Complaint Tracking Software), collaborate with field Assurance specialists regarding discrepancies or queries related to customer complaint.

●Study and understand nature of the complaint using available complaint information in the Trackwise.

●Perform decontamination on returned complaint samples in designated area by following FA Lab Decontamination Procedure/Work Instruction.

●Update Trackwise for preliminary evaluation of returned samples.

●Assists Quality Engineers in developing physical and functional test requirements to ensure specifications and regulations are met.

●Plans and coordinates engineering inspection and testing using all necessary measuring and testing equipment including Micro vu, and X ray machine.

●Conducts testing and provide evaluation results and photos of every stage, Update Trackwise with evaluation results and Provide photos on SharePoint.

●Understands and follows company procedures and regulatory requirements.

●Maintain biohazard and decontamination lab. Responsible for ordering supplies, maintaining inspection tooling, shipping samples, maintaining inventory and performing safety checks.

Accomplishments:

●I had started as Temporary employee, got hired on full time position within 90 days based on fast adoptions of system and strong work ethics.

●Expertise in technical evaluation.

●Provide support to train new hired employee.

Quality Control Stability Associate January 2017 to January 2019

Insys Development Company Inc., - Chandler, AZ

●Responsible for managing the Quality Control Stability program as per protocol per GMP and ICH guidelines.

●Worked directly with scientists to collect and analyze data for GMP documentation and reports.

●Managed stability testing using a Part 11Testing and Stability Management System to initiate and complete stability programs.

●Maintained inventory for laboratory equipment and supplies using an ERP system which including ordering and maintaining stock supplies.

●Responsible for controlled substance inventory used by the scientists for testing which including receipt, issuance, and reconciliation per DEA requirements

●Provide support for regulatory agency inspections (FDA, DEA).

●Maintained documents in a eDMS system for GMP documentation.

Accomplishments:

Worked with QA to establish an inventory management system for controlled substances which led to efficiency in annual inventory and reduced discrepancy inventory errors.

Analytical Lab Technician August 2016 to January 2017

Marlyn Nutraceuticals - Phoenix, AZ

●Performed raw material, In-process, and Finished product analysis (including microbial testing) using Wet-Chemistry, Titrations (automated), Manual Titration, Refractometers, Tap Density, Particle Analyzer, Water Content (Karl Fisher), Loss on Drying, Disintegration, Friability, Water activity, and other routines QC analytical instruments.

●Performed GMP functions and good documentation practices by following SOPs, accurately recording data, perform calculations, and resulting reporting.

●Worked independently and assisted other quality control personnel when needed.

Inventory Management Specialist November 2015 to June 2016

Lotus International Company) - Canton, MI

●Managed inventory as per planning and requirement.

●Responsible for inventory throughout the production cycle from incoming material, shipping and distribution, and storage

●Maintained effective communication with other departments to keep track of inventory, provide day to day metrics to departments.

●Performed inventory audits and cycle counts as applicable.

Accomplishments:

●Successful execution of tasks with a fast adaptation of processes.

●Maintained zero discrepancies of stock during tenure.

Quality Control Associate February 2015 to August 2015

Advance Engineering Company - Canton, MI

●Performed First Article Inspection of Metal Stamping

●Performed in Process Inspection of Welded Part Assembly

●Regulated quality of Deep Drawn Metal Stamping. Welded part assemblies, rework and sorting departments.

●Managed and trained staff for rework and sorting departments.

Accomplishments:

●Led and managed independently all quality related tasks during off-shift operations.

Inventory Manager August 2008 to March 2010

Nitiraj Engineers Ltd. - Parwanoo, Himachal Pradesh, India

●Responsible for inventory management operations.

Lead Quality Assurance & Lab Co-Ordinator. August 2006 to October 2007

Ecoplast Ltd. - Valsad, India

●Responsible for inspection and testing of non-durable goods

EDUCATION

Associate Degree: Electronics and Radio Engineering

Government Girls Polytechnic, Surat, Gujarat, India

Diploma: Computer Multi Media

Xplore Design School, Valsad, Gujarat, India



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