Quality Systems Validation Specialist IV

<b>'The Power to Look Deeper'</b> <BR>Awarded the 2008 Grand Prize at the local Workplace Excellence Awards, Gen-Probe is a respected biotech employer of choice in San Diego and a global leader in the research, development, manufacturing and marketing of nucleic acid probe-based products used for the diagnosis of human diseases and for screening of donated human blood. We offer a state-of-the-art facility in a prime location with world-class benefits. We're currently looking for team members who have 'The Power to Look Deeper' in developing the best products, technologies and service. <BR><p> <BR><b>'The Power to Shape Your Future'</b> <BR>We are seeking a <b>Quality Systems Validation Specialist IV</b> who will be responsible for defining validation strategies and approving validation methods, studies and reports for instrument or process changes.</p><br><b><u>DESCRIPTION OF POSITION RESPONSIBILITIES:</b></u> <BR><ul><li>Active QS participant as a core team member and cross-functional project teams, i.e., MRB, PQC, etc.; able to provide guidance and suggest more efficient methods to the core teams <BR><li>Assures compliance with regulations and internal SOPs for validation efforts performed by internal/external personnel <BR><li>Remains current on FDA, ISO, and other regulatory requirements and standards applicable to validation policy and quality issues <BR><li>Establishes and evaluates adequacy of validation methods for new or modified processes, equipment or facility changes <BR><li>Reviews/approves validation protocols and reports in conjunction with the supporting data and documentation for adequacy and completeness <BR><li>Reviews/approves risk analysis for adequacy; able to evaluate changes to a design and associated risk documents <BR><li>Manages, reviews and approves Change Control packages for all types of changes <BR><li>Develops, collects, analyzes and presents department metrics & suggests corrective actions <BR><li>Conducts compliance audits of extremely complex documentation & data <BR><li>Leads and performs internal, external & 3rd party audits <BR><li>Pursues cross-training in analytical methods, cleaning, facility and utility factors, processes, equipment and software validation <BR><li>Oversees department training programs <BR><li>Develops quality systems, performs gap analysis, makes recommendations and initiates plans to improve existing systems <BR><li>Provides direction & mentoring to lower level QS personnel <BR><li>Manages resources associated with QS projects and communicates and provides recommendations to management if concerns exist. <BR><li>Works with QS management in development of department budget. <BR><li>Conducts complex, in-depth analysis of quality issues and process troubleshooting <BR><li>Creates/reviews/approves a master validation plans <BR><li>Assists in decision making for recalls, MDRs, field corrections &/or market recalls <BR><li>Interfaces with other departments, partners, suppliers & Regulatory Bodies to recommend new processes & technology and to ensure implementation of good business and compliance practices. <BR></ul><br><b><u>RELATED BUSINESS/TECHNICAL SKILLS, KNOWLEDGE, ABILITIES:</b></u> <BR><ul><li>Basic knowledge of QSR & ISO requirements. <BR><li>Working knowledge of spreadsheets and word processor applications. <BR><li>Familiarity with concepts of statistics, sampling plans and statistical analysis. <BR><li>Familiarity with analytical methods, equipment, process, software, cleaning and/or facility/utility validations. <BR><li>Familiarity with automated manufacturing equipment. <BR></ul> <BR><b><u>EDUCATION AND EXPERIENCE REQUIREMENTS:</b></u> <BR><ul><li>Typically requires BS and 10-12 years related experience or MS and 8-10 years related experience. <BR></ul><br><b>Gen-Probe</b> offers a dynamic and innovative work environment along with excellent benefits that include company sponsored medical/dental/vision benefits, stock options (NASDAQ:GPRO), bonus potential, 401(k) with company match, paid vacation/sick time /holidays, assistance with continuing education, on-site fitness center and our own Waterfall Caf&eacute;. <BR><p> <BR>We invite you to view our Career Video! <BR><b>http://www.view-career-video.com/videos/genprobe/</b> <BR></p> <BR>Please apply online by visiting: <BR><b>http://www.gen-probe.jobs </b> <BR><p> <BR>Gen-Probe is an Equal Opportunity Employer. All applicants will be given consideration regardless of race, sex, age, color, national origin, ancestry, medical condition, marital status, sexual orientation, citizenship status, religion, handicap status or veteran status.</p> <BR>

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