06/11/09
Will Williams
Suisun City, CA
Email: r1335@bio-link.org
Date Available:
ASAP
Education:
• University of Southern Illinois-Carbondale, College of Engineering
Bachelor of Science, Industrial Technology, anticipated graduation - Second Quarter 2009
• LEAN and Six Sigma Green Belt/Black Belt classes/training, 2008.
• The 7 Habits of Highly Effective People, Franklin Covey, 2007.
• Leadership development, Genentech, 2006.
• Communication development, Genentech, 2006.
• Total Quality Management Training, SIU, 2007.
• Time Management, Genentech, 2007
Biotechnology Skills:
• Validation: 3+ years experience in a fast paced production environment.
• Supervision: 2+ years experience as a Supervisor; “hands-on-style” focused on maximum productivity.
• Communication Skills: Excellent communicator, fluent Thai, Tagalog.
• Visionary: Maximize resources to get the job done; Experienced within FDA regulated environments.
• Computer Skills: Microsoft Office 2003, SAP, NovaManage, BPCS/POMS, MiniTab14 &15.
• Additional Skills: ERP, Validation
Work Experience:
Genentech, Inc. January 2006 to Present
Quality Specialist
• Work with Operational Excellence with implementation of SAP on the QA documentation side.
• Successfully represented Clinical Quality for Process Improvement (Kanban) for Pharm Production.
• Represented Clinical Quality for RCA.
• Assisted with streamline QA documentation process in regards to, Technical writing, releasing of documentation within timelines for Production use.
• Prioritizing teams on timelines for all aspects of business (e.g. Production, QA, QC, packaging).
• Help supporting QA Documentation SAP, as well as conflict resolution processes.
• SAP Go-to-guy for Change control team, Supervisor designated me for SAP Super User training.
• Review of Manufacturing Formulas & protocols to ensure compliance with FDA regulations.
Genentech, Inc. (Contractor, Adecco Scientific) March 2004 to December 2005
Document Coordinator
• Helped define rolls of newly developed Clinical Quality team.
• Drafted training material used for department new hires.
Bio-Rad Laboratories February 2002 to March 2004
Manufacturing Engineer
• Assisted in the development and execution of Process, equipment packaging validation
in the transfer of protocols, transportation studies, batch records drafted by 3rd party facility to comply with integrity of current manufacturing process.
• Accomplished inspections and certifications of QA quality worthiness; FDA standards of quality and safety were met.
• Drafted & edited SOP’s, Raw material specifications, Purchasing Specifications and manufacturing formulae & Manufacturing protocols.
• Recognized as Quality Assurance Honor Roll member, dedication and attention to detail.
• Drafted and edited IQ, OQ, PQ protocols according to company SOPs.
• Performed equipment qualifications machines, chambers, Lyophilizer (using Virtis & Kaye Validator)
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