Data Entry Inspection Manager

Aicha Frankus

*** ****** ** # *

Providence, RI *2905

Cell: 857-***-****

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

SKILLS

•Manufacturing, Quality Control & Assurance- cGMP & ISO Experience

•Inspecting & Approving - Incoming, In process, and finish goods

•Lab Technician experience

•Utilize various measuring equipment devices

•Blue prints schematics, and drawings interpretation

•Proficient in data entry and Microsoft Office

•Fluent in three languages

EXPERIENCE

Bio-Detek - Rumford, RI July 2017 to March 2022

Quality Inspection Manager (Incoming and Final)

•Performed quality inspection and testing of raw materials for conformance to specification based on FDA & ISO regulations, using testing instruments, inspections procedures and engineering drawings.

•Ensured product and amount received reflects part list as well as prepared inspection sheet/labels

•Follow SOP for each raw material to make sure it meets DHR requirements

•Perform QC testing of final product to ensure compatibility with retains using the

Company’s Quality System

•Initiated DMR (Discrepant Material Report) for non-conforming materials and finish goods

•Maintained daily quality equipment logs for all instruments and machines used in

Production

•Responsible for the entire Quality Assurance and Control department

•Performed in house and external audits regularly

•Calibrated equipment and devices whenever necessary

•Ability to use all measuring devices including micrometers, calipers, and drop pins.

•Ability to work from schematics, drawings, and blueprints

•Review/Approval of all facility documentation

•Initiate Deviations, Investigations, Change Controls, CAPA’s and CoA’s

•Create Manufacturing, Packaging and Test Method Validation Protocols

•Writing/Revising SOP’s when needed

•Ensuring regulatory compliance throughout facility

•Investigation of customer & Vendor complaints, as well as resolving the issue in a timely manner

•Assist in gathering Key Performance Indicators (KPI’s) for quality related activities

•Solid knowledge of cGMP/GLP and ability to read technical procedures or government regulations.

•Experience with Electronic Data Management Systems

Lansco Colors - Warwick, RI March 2015 to July 2017

Quality Assurance & Control Supervisor

•Performed quality control testing on incoming paint, ink, and plastic samples using proper testing procedure established for each product.

•Prepare testing buffer and vehicle for each brand used in the Lab

•Review results obtained for errors before submitting complete results to Lab manager

•Operate, trouble shoot, and calibrated lab equipment and machinery daily

•Ordered lab supplies from various vendors

•Ensure technicians get an acceptable yelled on ever lot production

•Maintained monthly inventory while reporting final data to the Director of QA/QC dept.

•Assign daily tasks for all the Quality Inspectors on the production floor

•Facilitate Quality control weekly meetings with Quality and Manufacturing departments

Immunetics, Inc - Boston, MA 2006-2014

Lab Technician/Quality Control Coordinator

•Assist with routine manufacture of diagnostic test kits, Western Blots and ELISA's in a cGMP facility.

•Visually inspect small parts under a microscope

•Performed final inspection for all diagnostic kits

•Proper documentation of the manufacturing process according to cGMP requirements.

•Preparation of all kit components including buffers and controls.

•Used balances to weigh chemicals and buffers.

•Train other Manufacturing Associates and Technicians.

•Track and order necessary chemicals and materials needed to manufacture the products.

•Perform vendor qualification procedure on regular bases.

•Assist the R&D labs whenever needed.

•Perform QC procedures using the company's Standard Operating Procedure.

EDUCATION

CityLab Academy, Boston University School of Medicine

Certificate in Biomedical Laboratory Sciences

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