Brittaney Obienu 203-***-****

Relocating to the Alabama/Georgia area January 2024 ad02mk@r.postjobfree.com

Professional Profile

Quality Control Manufacturing Chemist Professional with 11+ years of experience in a regulated manufacturing industry. In search of a laboratory position that will allow use of my experience, increase my skill set, further my career and grow along with the company.

Self-starter, hardworking and reliable

Quality Team Member with cGMP audit experience

Experienced with USP, FCC & NF databases ensuring annual compliance

ISO 13485 & 21 CFR 211, 212 & 820 experience

FDA Readiness Team Member

Experience with TOC analyzer, autotitrator, viscometer, spectrometer, and GC

Professional Experience

Medline Industries, LP (Aplicare Inc. formerly Clorox Healthcare), Meriden CT

2012 – Present

Chemist

Achievements:

Medline Quality Quarterly Kaizen Award Winner multiple times

Medline Quality Quarterly Group Teamwork Award Winner

Employee of the month

Trainer for all new lab technicians and chemist

Responsibilities:

Current daily responsibilities for drug, device and cosmetic products include:

oDaily opening of laboratory including verification of all lab equipment (auto-titrators, scales, incubators, pH probes, etc.).

oChemistry and microbiological Sampling, testing, and SAP release of chemical raw materials

oTesting and SAP release of batch liquids

oFinished Product Release Testing and stability testing, including seal integrity and container closure

oSample submission for outside laboratory testing via STAR LIMS

oCoordinate release of materials for production and minimizing Quality caused down time

oEnsuring compliance to ISO 13485 & FDA regulations as per the QMS

oReview work done by others to ensure company policy compliance

Collaboration with cross functional teams using problem solving skills to resolve equipment and process related issues

Calibration administrator for entire facility, issuing and tracking identification for each piece of equipment, ensuring all departments are aware of what equipment requires validation each month and ensuring said validations have been completed and are stored appropriately in the electronic system.

Perform calibration of production and quality testing equipment

Training, coaching and developing skills to ensure adequate coverage within department

QMS document reviews and edits (familiar with both Master Control & ETQ Reliance)

Proficiency in bench chemistry, reagent prep, manual titrations, viscosity, TOC testing, and pH

Experience with TOC analyzers, autotitrators, viscometers, and spectrometers

Purchase chemicals and lab sampling or preparatory materials via POs in the SAP ECC system

Familiarity with Lotus Organizer and Epicor programs

Execution of nonconformance reports, nonconforming material reports, change controls, like-for-likes, internal compliance audits, out of specification investigations, deviations, out of tolerance investigations, technical reports, risk assessments, gap assessments, and corrective and preventative actions

New Mexico Tech, Chemistry Department

2009

Researcher

Responsibilities:

Examined aqueous-phase reforming of ethanol over a platinum aluminum oxide support

Gained knowledge in maintenance and instrumentation of a GC

Education

University of New Haven (West Haven, CT)

Bachelor of Science, Chemistry and Forensic Science (2006-2010)

Minor, Mathematics and Criminal Justice

Certificate, Law Enforcement Science

Magna Cum Laude, GPA 3.83/4.00

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