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Quality Control

Location:
San Diego, CA
Posted:
December 30, 2019

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Resume:

Jennifer Gambill Ph: 858-***-****

**** ****** ******** ** #*** ada6d6@r.postjobfree.com

San Diego, CA 92119

Professional Summary:

I am a dedicated and skilled Quality Control Medical Technologist with 10+ years’ experience combining Quality and Customer Service. I am seeking a career with a company which offers upper mobility and best utilizes my experience and training. I have expert knowledge of laboratory GMP and HIPPA compliance with an established career working in Quality and Clinical settings. I believe in exceeding expectations and supporting quality patient care and education. I am also committed to improving the continuous process of accurately diagnosing diseases that lead to cures.

Areas of Strength and Expertise:

Meticulous attention to detail, well organized and strategic thinker with the vision and tactical skills to achieve corporate goals.

Proficient in GMP, ISO, CAP and HIPPA compliance

Analytical skills; Implementation and Validation of instruments; Strong technical writing and editing skills in SOPs, EOP’s Validations, Change Orders and Reports.

Effective team player; able to set expectations and energize teams to assume new challenges.

Excellent verbal and written communication skills and the ability to interact professionally with a diverse group.

Experience:

Quality Control Medical Laboratory Technician II Aug 2008-Current

Scantibodies Laboratory, Inc Santee, CA

Responsible for biological and chemical evaluation of raw material, in-process, and final release testing including instrument calibration, quality control, maintenance and troubleshooting through a quality system.

Responsibilities/ Duties:

Manage and organize control projects, stability, homogeneity and value assignment testing

Daily communication with all submitting departments to ensure quality and reliability of all testing.

Verification and completion of all QC testing results prior to release.

Maintenance of inventory control, ordering/receiving equipment and supplies.

Assisted supervisor in Establishing, validating and implementing a laboratory information management system, BlazeLIMS in order to manage and track testing within in the laboratory environment, including training all necessary personnel without any interruption or impact to production.

Maintained the Quality Control Program, scheduled preventative maintenance, repairs, and ensured laboratory instrument and pipette calibration.

Laboratory Responsibilities:

Proficient with a variety of immunoassay and chemistry analyzers by Roche, Abbott, Beckman Coulter, and Ortho Diagnostics.

Volumetric Moisture Analysis using the Karl Fisher Method, LAL, Osmolality, and Titer.

Sample Integrity Testing using UV/VIS Spectrophotometer and Colorimetric/Manual Assays.

Bioburden, Sterility testing, and Identification.

Pipetting, Buffer Preparation, Dilutions, Concentrations.

Organize and store all chemicals substances, fluids and compressed gases according to safety instructions

Accession samples and results into BlazeLIMS.

Result preparation, corrections and Excel spreadsheets.

ELISA, CLIA, RIA, and EIA

Ensured that all safety guidelines are always followed strictly and maintained a clean and orderly environment

Quality Document Control Specialist Jan 2006-Aug 2008

Nuvasive, Inc San Diego, CA

-Enforced and controlled GMP Practices. Stored, managed, and tracked all company documents. Worked closely with Marketing, Engineering, Quality Regulatory Affairs as well as Quality Engineering with to research and resolve discrepancies.

Responsibilities/ Duties:

Maintained files on a manual document control system, in electronic and hard copy.

Released and updated drawings and specification

Maintained documents to ISO 9001 Standards

Created document revision, distribution, obsolescence, and retention files.

Observed and assisted in cadaver labs for hands-on training, education, and development of new surgical techniques regarding spinal implants and devices.

Ensured that the most current revision of controlled documents were available for use

Tracked change orders through change order process, ensured changes were approved and documents were updated before release, archived older revisions of documents.

Completed, configured, and revised Engineering Change orders.

Education:

James Madison High School Sep 1998-Jun 2002

High School Diploma; 4.0 GPA

San Diego, CA

San Diego State University

Business; 3.75 GPA Sep 2002- Jul 2005

San Diego, CA

Grossmont College Jan 2018-Current

Currently Attending

El Cajon, CA

Additional Skills:

MS Office; Excel, Word, Powerpoint, Publisher

BlazeLIMS, Track-it, Misys



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