Quality Assurance

Ekundayo O. Inyang

*** **** ***** ***** *********, NJ 08902 Cell: 973-***-**** email: acofrm@r.postjobfree.com

Objective: Recent graduate with excellent research, time management and critical thinking skills seeking to gain

employment in a laboratory and research position with opportunity for advancement.

Technical Skills and Core Competencies

• Tissue and Culture techniques,

Sterilizations, Operating basic Lab equipment, familiar with FDA protocols, good with cGMP guidelines,

Calculating basic solutions and Calibrations, Basic pipetting.

• Microscopy, Microbial Culturing and centrifuge

• Microsoft Office

Programs (Word, Excel, PowerPoint, and Outlook), LIMS and Trackwise.

• Proficient with

communication skills, both written and verbal

• Highly motivated and willing to work

flexible schedule to succeed

Professional Experience

International Technidyne Corporation April 2014 to present

Biomedical Quality Assurance/ Control Analyst Edison, NJ

• Assure quality products and processes; establish quality and reliability standards by working

cross-functionally and with Senior Leadership to study product and consumer requirements

• Establish raw material standards by studying manufacturing and engineering requirements foe

device testing methods and procedures.

• Establish in-process product inspection standards by studying manufacturing methods

• Establish standards for the disposition of finished product for device test methods and procedures

• Establish rework standards for device inspection and testing methods and procedures

• Establish product quality documentation system by writing and updating quality assurance

procedures

• Maintain product quality by ensuring compliance with quality assurance policies and procedures

related to relevant regulations

• Prepare product and process quality reports by collecting, analyzing, and summarizing data and

trends

• Perform testing of biological raw materials and finished goods per relevant SOP, Ensure and

maintain compliance with the Company’s quality system requirements through training and adherence to policies,

procedures and processes.

• Perform testing for product validation and process validation on existing products; publish data

accordingly

• Perform testing and prepare reports as required for investigation of non-conforming material and

for performance evaluations

• Coordinate, perform testing and prepare reports for various special projects as deemed necessary

by technical review team

• Responsible for analyzing data and tracking relevant trends

• Perform QC record audits as required under standard QA procedures

• Document all test results and maintain existing product/process validation test results and

maintain validation test results (including electronic records)

• Maintain product testing database and perform relevant statistical analyses including trend

analysis

• Maintain proper laboratory housekeeping in work place with the QC Coordinator to ensure the

laboratory is always equipped to handle routinely scheduled testing and anticipated increases in test schedule

• As required, work cross-functionally to investigate and resolve non-conforming material and

performance issues

Ekundayo O. Inyang

220 Lisa Place North Brunswick, NJ 08902 Cell: 973-***-**** acofrm@r.postjobfree.com

Irvington Medical Imaging Center February 2011 to September 2013

Office Manager/ Radiologist Assistant Irvington, NJ

• Followed infection control procedures. Maintained patient privacy and confidential patient information.

• Ensured safety and well-being of patients.

• Cleaned and sterilized instruments and disposed of contaminated supplies.

• Assisted radiologist in performing MRI scans

Everest Medical Laboratory August 2008 to August 2010

Phlebotomist/ Lab Assistant Edison, NJ

• Assisted in performing lab tests as per in accordance to SOP and communicated results to physicians.

• Managed caseload of 20 clients, providing education, treatments, and venipuncture and routinely retracted patient

throat cultures and prepared them for lab submission to regulatory procedures.

• Collected blood and other laboratory specimens and prepared them for lab testing according to regulatory

procedures.

• Ensured Cleanliness and sterilization of lab instruments and disposed of contaminated supplies sustained at

satisfactory level of cGMP and MSDS guidelines.

• Worked as part of team to execute proper care of specimens and providing results in a timely manner.

• Ensured safety and well-being of patients according to HIPPA and FDA guidelines.

• Trained new staff on quality control procedures.

• Ensured compliance with company quality standard, FDA and OSHA guidelines.

Education

B.S Biology/ Minor in Health Kean University, Union, December 2013

Certified Phlebotomist National Career Institute, East Orange, NJ June 2007

Certificate: CPR, Phlebotomy

Contact this candidate