Quality Manager
Resume:
VANESSA DOTO
g2k428@r.postjobfree.com
EXPERIENCE
BBRAUN, CAPS. Jan 2010-Present
Quality Control Coordinator
• Responsible for ensuring all training is in compliance with company policies and GMP. Knowledge of Iso-train.
• Complete weekly environmental monitoring and documentation of all validations, aseptic technique qualifications and sterility testing from the cleanroom.
• Verify and coordinate calibration of all equipment on site with appropriate vendors.
• Compile monthly and quarterly reports in accordance to QA templates and GDP.
• Assure facility compliance to SOPs, cGMP, and USP<797> though scheduled and unscheduled audits.
• Knowledge of all relevant SOPs and their application.
• Conducted and compiled findings on site investigations as needed.
XCELERON INC Jun 2008-Jun 2009
Lab Analyst
• Involved in sponsor studies testing biological samples for radioactivity. Received, stored and coded samples according to SOPs.
• Trained in radiation safety. Worked with radioactive samples on a daily basis.
• Ran HPLC instruments for fraction collection, prepared samples through a graphitization process for final analysis on an Accelerator Mass Spectrometry (AMS), Liquid scintillation counter (LSC), Oxidizer and CHN analyzer. Performed plasma extraction methods.
• Processed and co-audited all data as it was generated; all according to GLP regulations. Compiled data summaries, updated SOPs, assisted in report writing.
• Along with another member of the safety committee I worked to bring all codes up to US regulations. Included completion of risk assessments throughout the lab.
• In charge of lab inventory, included purchasing and receiving all lab materials.
• Coordinated with outside vendors to ensure all lab equipment was calibrated and up to GLP codes. Put in place a QC checklist for all due dates on all lab equipment.
ALKERMES Nov 2005-Mar 2008
Research Associate II
• Supervised incoming analysts working on drug product characterization, along with other ongoing projects.
• Ran HPLC and Karl Fischer. Performed chemical and physical testing in the analytical development department and GMP compliance work environment.
• Analyzed and tested supporting product/process development, analytical method development, product characterization, validation, and stability.
• Updated and reviewed SOPs, protocols and reports.
• Provided GMP documentation of both chemical and physical data.
• Member of the training team to aid in overall effectiveness of testing in our labs.
• As Safety Representative, ensured labs were up to safety regulations. First responder certified.
• As part of the inventory team tracked solutions/materials to ensure enough supplies were available for testing.
AAA RADIATOR ENCLOSURES 2005-Mar 2008
Office assistant
• Receive and direct incoming phone calls. Schedule appointment with customers. Follow up on incoming emails in order to increase sales
• File and organize all orders, daily sales materials, phone and customer sales, for both manufacturing and retail/wholesale operations.
• Assist in all basic office duties, including purchasing/ordering of office supplies, and communication with the sales representative.
GENOMICS COLLABORATIVE May 2005-Nov 2005
Clinical data operator
• Updated databases for the companies extensive DNA repository
• Received and categorized all new samples upon arrival to the site.
• Entered all new confidential clinical data which was from different sites and research projects.
• Required good recognition skills as well as attention to detail to categorize information correctly.
EDUCATION
WORCESTER POLYTECHNIC INSTITUTE (WPI), Worcester, MA
Bachelor of Science, Biology/Biotechnology, Graduated May 2005
Completed both, Interactive Qualifying Project (IQP) and Major Qualifying Project (MQP), as required for degree completion.
Contact this candidate