Quality Control Chemist

Crystal L. James-Owens III

**** *. **** ******, ***** 3, Bridgeview, IL 60455

Email: actafk@r.postjobfree.com

Phone: 773-***-****

EXECUTIVE SUMMARY

Extensive experience in laboratory and regulatory operations. Nearly 13 years of Quality Control/Regulatory and/or Laboratory Experience. Excellent and proven track record in improving profitability, efficiency, and productivity. Five years of experience as an Ace It Teacher. Team player, quick learner, articulate, and passionate about quality and customer service relationships.

EXPERIENCE

Sylvan Learning Center, Chicago, IL November 2015 to Present Ace It Teacher (K-12) October 2014-May, 2015

October 2013-July 2014 October 2012-July 2013 November 2011-July 2012

●Provided reading intervention for Chicago Public, Magnet, and Charter Schools (K-12).

●Significantly improved reading and Math scores via “Ace It” Program powered by Sylvan Learning Center.

Baxter Pharmaceuticals, Round Lake, IL September 2010-December 2010

Quality Associate in Global Compliance

●Effectively executed CAPA reports, protocols, and Supplier Quality investigations.

●Business resource (SME) for compliance requirements as related to FDA for Medical Devices for SQ.

●Participated in Supplier Quality (SQ) and Purchasing Supplier Management’s (PSM) Internal and External FDA Audits.

●Played a significant role in the integration of the PSM and Supplier Quality departments.

●Reviewed protocols, SQ investigations and CAPA reports for accuracy and compliance.

SC Johnson, Racine, Wisconsin January 2008-August 2008

Regulatory Research Analyst

●Created Standard Operating Procedures (SOPs) and Policies for the Global Safety and Regulatory Affairs Division (GSARA).

●Designed new SOP formatting template for all procedures within the Global Regulatory Affairs (GRA) department.

●Created MSDS sheets.

●Trained in US Import/Export regulations.

●Effectively communicated internal and external data responses within the PLM system.

●Participated in several projects, i.e. Data Cleansing Project for raw substances.

Johnson Diversey Inc., Sturtevant, Wisconsin March 2007-December 2007

Technical Analyst

●Harmonized QA laboratory methods by identifying, reviewing and creating Quality Assurance laboratory methods for JDI plants in Canada, U.S, and Europe by utilizing internal, ISO and ICH procedures/guidelines for laboratory method consolidation.

●Reviewed and coordinated changes in material sourcing, processing methods, packaging, and filtering procedures.

●Researched suppliers/vendors for Material Safety Data Sheets (MSDSs) of raw materials for SKU migration interplant moves.

●Created MSDS documents.

●Provided QC assistance for various projects in the Value Chain Department.

Nanosphere Inc., Northbrook, Illinois January 2006-April 2006

Technical Scientific Writer

●Created Standard Test Methods, Standard Operating Procedures, and Policies for the Quality Control (QC) department.

●Audited QC files/data/documents for compliance.

●Developed and maintained new Cal-Alert program for digital pipettes, HPLCs, IC and timers.

●Liaison for all instruments (FTIR, IC, and HPLC) service contracts.

American Pharmaceutical Partners, Melrose Park, Illinois January 2005-May 2005

Quality Control Supervisor

●Ensured all oncology drugs were compliant with FDA and USP regulations either by working directly with the Analytical Chemist and/or updating protocols.

●Supervised a team of 5 QC Chemist/Analysts for various laboratory testing.

●Prepared trending reports for unused data.

●Conducted laboratory investigations.

●Reviewed, audited, and signed-off on all laboratory instrument calibrations.

Abbott Laboratories, North Chicago, Illinois Nov. 1996-Sept. 2004

QA Laboratory Team Leader April 2001-September 2004

●Followed all cGMP and cGLP regulations as enforced by the FDA.

●Initiated, wrote and tracked CAPA reports/investigations.

●Initiated and wrote laboratory investigations, change request, and deviations.

●Co-validated methods for quality control laboratory use.

●Participated in laboratory audits (U.S. Food and Drug Administration, Customer, and Corporate).

●IT Software Tester for all software related to QA laboratory operations.

●Investigated, audited and updated all USP and EP procedures for QA Fermentation Laboratory.

●Revised and created STMs and BOPs for the QA analytical laboratories.

●Assisted sister company in Mexico with laboratory and document set-up.

●Provided laboratory assistance for customers (Planning, MQA, Marketing, Batch Record review, Regulatory, Manufacturing, and Research and Development).

●Performed laboratory tests as needed (HPLC, GC, IR, UV-VIS Spectrophotometry, etc.).

●Verified laboratory data and database release results.

●Ensured all products met EP, USP, ICH guidelines and internal specifications.

●Dispositioned lots and performed code changes for release of pharmaceuticals.

●Served on several internal customer committees as a Consultant for (Batch Record Review, Manufacturing, Planning, Regulatory, and Customer Complaints).

QA Lab Technician November 1996-April 2001

●Performed laboratory testing via (HPLC, GC, IR, UV-VIS Spectrophotometry, etc.).

●Dispositioned lots and performed code changes for release of final products.

●Verified laboratory data.

COMPUTER SKILLS

●Microsoft Office (Word, Excel, PowerPoint)

●Millennium Chromatography System

●Laboratory Information Management System (LIMS)

●Chromatography Analytical System (CHROM)

●Business Planning Control System (BPCS)

●Trackwise

●Instrument Maintenance and Calibration System (IMCS)

●Project Lifecycle Management (PLM:Regulatory Affairs Computer System)

EDUCATION

Chicago State University, Chicago, Illinois

Bachelor of Science in Biology, Minor in Chemistry, Math & Psychology

CERTIFICATION

Completed Clinical Research Associate (CRA) Classes @ MITS (Management & Information Technology Systems), Gurnee, IL

Pursuing CRA Certification

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