Quality Assurance Manager
Resume:
Wendi Marie Van Muijen
Bakersfield, CA ***** ● 714-***-**** ● *****.*********@*****.***
NuSil Technology
Bakersfield, California
A leading formulator of silicone compounds for aerospace, healthcare, electronics and other applications requiring precise and predictable materials performance.
Quality Assurance Analytical Supervisor, April 2011 – Present
• Conduct studies and projects as related to test method development and regulatory submittals.
• Investigate testing process and product improvement for silicones and active pharmaceutical ingredients.
• Oversee proper traceability of QA Chemists’ projects and supervision of department personnel.
• Write specific procedures and follow proper documentation procedures, including keeping up-to-date and correct records.
• Train and oversee department personnel and assist in hiring decisions, termination, and review performance of direct reports.
• Participate in FDA audit and implementing corrective actions.
• Monitor and assure standard operating procedures and good manufacturing practices are followed.
• Assist in operational qualification/performance qualification of newly acquired equipment.
• Review and approval of company documents related to batch records, out of specification reports, test methods, in-process testing, incoming material testing, packaging, and manufacturing.
• Basic understanding in various wet chemistry and analytical test methods.
Allergan
Irvine, California
A health care company focused on discovering, developing, and commercializing innovative pharmaceuticals, biologics and medical devices that enable people to live life to its greatest potential.
Associate Professional Documentation, April 2010 – March 2011
• Perform quality assurance edit and review of research and development documentation (reports and protocol) to be submitted to FDA for product validation purposes.
• Route pending documentation for approval process via documentum systems CORAL, FirstDoc, and SharePoint.
• Engage in departmental AIP and Kaizen development events.
• Create new document templates to standardize company formatting.
• Collaborate with authors to ensure accuracy and consistency of written materials.
• Manage and troubleshoot sample submissions via Access and Excel database.
Siemens Healthcare Diagnostics
Los Angeles, California
A leading manufacturer and distributor of high quality medical diagnostic reagents and equipment. Originally Diagnostic Products Corporation (DPC), Acquired by Siemens in 2006. ISO 9001:2000 and ISO 13485:2003 Certified.
Document Review Specialist / Quality Assurance III, 2008 – 2010
• Provided timely and thorough review of company confidential production and manufacturing documentation to ensure protocol adhered to in accordance with FDA and ISO regulations. Including but not limited to an understanding in QSR, cGMP, GDP, and GLP.
• Initiated monthly departmental meetings to discuss errors and implemented one-on-one training with staff.
• Introduced numerous new lab measures, co-authored over a dozen standard operation procedures, and assisted in new and revised batch records through quality change control procedures.
• Through detailed review of production documents, identified deviations, initiated and recommended steps taken to minimize/eliminate future deviations.
• Monitored laboratory equipment while keeping open communications with external vendors allowing renewal of service contracts and warranties.
• Scheduled field service for calibrations and preventative maintenance and given ample notification to lab workers which assured minimal production interruptions. Repaired or scheduled repair of malfunctioning equipment.
• Directly assisted management with internal audits and ISO audit. Aided in implementing corrective actions.
Pacific States Marine Fisheries Commission
Los Alamitos, California
An organization helping resource agencies and the fishing industry to sustainably manage, conserve, and develop the valuable Pacific Ocean resources in California, Oregon, Washington, Idaho, and Alaska.
Fish Technician, 2005 – 2008
• Assisted scientists with duties related to the protection, preservation, propagation, and sampling of Southern California ocean fish species and the preservation or enhancement of their habitat.
• Communicated with commercial / recreational fisherman and the public to collect accurate information on fish and assure regulation compliance with Department of Fish and Game.
• Collected scientific data on fish length, weight, gender, species identification, location, and depth as well as other pertinent information (e.g. fin clippings, otoliths, tags) for research by DF&G biologists.
• Gathered carapace information on lobster and scallop.
• Educate fishermen on pollution and toxicity in fish.
• Inform public and answer questions pertaining to marine life.
Education
California State University Long Beach 2006
BS in Marine Biology and BS in Zoology
Minor in Chemistry
Technical Skills
Proficiency in Office 2007 and older
Basic knowledge of statistical software JMP 8.0
Beginning understanding in Access
Understanding in SharePoint, FirstDoc, and CORAL electronic documentum systems
Knowledge of scientific writing style guidelines
References
Marie Mc Kenna, Validation Manager, Siemens Healthcare
Phone: 310-***-****
Phyllis Yu, Supervisor, Allergan
Phone: 714-***-****
Ryan Beahm, Lab Technician, NuSil Technology
Phone: 661-***-****
Contact this candidate