Quality System Application Specialist

<body topmargin=0 leftmargin=0 marginheight=0 marginwidth=0> <table cellpadding=0 cellspacing=0 border=0><tr> <td valign="top" colspan=2 height=82 BGCOLOR="#9900CC" TEXT="#080000"> <div> <FONT SIZE="6" COLOR="#FFFFCC" FACE="Book Antiqua" ><B>The Artac Seel Company, Inc.</B></FONT><FONT SIZE="3" COLOR="#FFFF99" FACE="Book Antiqua" ><B> </B></FONT><FONT SIZE="3" COLOR="#FFFF80" FACE="Book Antiqua" ><B> </B></FONT><B>   </B><A HREF="index.htm" TARGET="_top" TITLE="TASC Home Page"><U><B>Home Page</B></U></A><B> </B></div> <div> <A HREF="id45.htm" TARGET="_top" TITLE="FULLTIME POSITIONS"><U>FULL-TIME POSITIONS</U></A>   |   <A HREF="id56.htm" TARGET="_top" TITLE="CONTRACT POSITIONS"><U>CONTRACT POSITIONS</U></A>   |   <A HREF="id48.htm" TARGET="_top" TITLE="RECRUITING"><U>RECRUITING</U></A>   |   <A HREF="id46.htm" TARGET="_top" TITLE="CONSULTING"><U>CONSULTING</U></A>   |   <A HREF="id49.htm" TARGET="_top" TITLE="ABOUT US"><U>ABOUT US</U></A></div> <div> </div> </td> </tr><tr> <td valign="top" width=340 BGCOLOR="#999980" TEXT="#080000"> <div> <B>Ellen Capito-Wightman, President</B></div> <div> <B>Corp. Phone  (860) 535-4419</B></div> <div> <B>FAX (860) 535-1842</B></div> <div> <A HREF="mailto: ellen@artacseel.com" TARGET="_top" TITLE="mailto: ellen@artacseel.com"><U><B>E-Mail to Ellen</B></U></A></div> <div> <B><U>FULL-TIME POSITIONS</U></B></div> <bR> <div> <A HREF="id105.htm" TARGET="_top" TITLE="Global Medical Affairs Disease Leader (E"><U>Global Medical Affairs Disease Leader (Exec. Dir)</U></A></div> <div> <A HREF="id103.htm" TARGET="_top" TITLE="Exec. Dir., Clinical Research Physician,"><U>Exec. Dir., Clinical Research Physician, Leukemia</U></A></div> <div> <A HREF="id104.htm" TARGET="_top" TITLE="Global Exec. Dir/VP Phase 1 Leader"><U>Global Exec. Dir/VP "Phase 1 Leader"</U></A></div> <div> <A HREF="id102.htm" TARGET="_top" TITLE="Dir., Multiple Myeloma Marketing"><U>Dir., Multiple Myeloma Marketing</U></A></div> <div> <A HREF="id101.htm" TARGET="_top" TITLE="VP Clinical and Medical Affairs"><U>VP Clinical and Medical Affairs</U></A></div> <div> <A HREF="id100.htm" TARGET="_top" TITLE="Senior Dir., Translational Medicine"><U>Senior Dir., Translational Medicine</U></A></div> <div> <A HREF="id99.htm" TARGET="_top" TITLE="Director Medical Affairs Oncology"><U>Director Medical Affairs -- Oncology</U></A></div> <div> <A HREF="id98.htm" TARGET="_top" TITLE="Clinical Submission Manager"><U>Clinical Submission Manager</U></A></div> <div> <A HREF="id97.htm" TARGET="_top" TITLE="Senior BiostatisticianProgrammer Pharma"><U>Senior Biostatistician-Programmer - Pharmacovigilance </U></A></div> <div> <A HREF="id96.htm" TARGET="_top" TITLE="Senior Medical Reviewer, Drug Safety "><U>Senior Medical Reviewer, Drug Safety </U></A></div> <div> <A HREF="id95.htm" TARGET="_top" TITLE="Director, Solid Tumor Marketing"><U>Director, Solid Tumor Marketing</U></A></div> <div> <A HREF="id94.htm" TARGET="_top" TITLE="Director, Regulatory CMC"><U>Director, Regulatory CMC</U></A></div> <div> <A HREF="id93.htm" TARGET="_top" TITLE="Director IM Forecasting and Planning"><U>Director IM Forecasting and Planning</U></A></div> <div> <A HREF="id92.htm" TARGET="_top" TITLE="Senior Mgr., IVRS Central Management"><U>Senior Mgr., IVRS Central Management</U></A></div> <div> <A HREF="id91.htm" TARGET="_top" TITLE="Manager, Safety Quality Assurance, Globa"><U>Manager, Safety Quality Assurance, Global Drug Safety</U></A></div> <div> <A HREF="id90.htm" TARGET="_top" TITLE="Research Scientist I / II"><U>Research Scientist I / II</U></A></div> <div> <A HREF="id88.htm" TARGET="_top" TITLE="Associate Director/Director, Regulatory "><U>Associate Director/Director, Regulatory Affairs, Oncology</U></A></div> <div> <A HREF="id75.htm" TARGET="_top" TITLE="AD/Trail Management, Translational Medic"><U>AD/Trail Management, Translational Medicine(TM)</U></A></div> <div> <A HREF="id72.htm" TARGET="_top" TITLE="Associate Director, Regulatory Affairs, "><U>Associate Director, Regulatory Affairs, Oncology</U></A></div> <div> <A HREF="id71.htm" TARGET="_top" TITLE="Associate Director, Manufacturing Operat"><U>Associate Director, Manufacturing Operations</U></A></div> <div> <A HREF="id53.htm" TARGET="_top" TITLE="Compliance Project Sr. Specialist "><U>Compliance Project Sr. Specialist </U></A></div> <div> <A HREF="id65.htm" TARGET="_top" TITLE="Senior Director, Lead Global Product Saf"><U>Senior Director, Lead Global Product Safety Physician </U></A></div> <div> <A HREF="id76.htm" TARGET="_top" TITLE="Senior Medical Reviewer, Drug Safety"><U>Senior Medical Reviewer, Drug Safety</U></A></div> <div> <A HREF="id52.htm" TARGET="_top" TITLE="Director, Lead Global Product Safety Phy"><U>Director, Lead Global Product Safety Physician </U></A></div> <div> <A HREF="id86.htm" TARGET="_top" TITLE="Clinical Research Scientist, Oncology"><U>Clinical Research Scientist, Oncology</U></A></div> <div> <A HREF="id85.htm" TARGET="_top" TITLE="Associate Director, GLP Quality Assuranc"><U>Associate Director, GLP Quality Assurance </U></A></div> <div> <A HREF="id84.htm" TARGET="_top" TITLE="Medical Writer, Scientific Communication"><U>Medical Writer, Scientific Communications</U></A></div> <div> <A HREF="id81.htm" TARGET="_top" TITLE="Director/Sr. Director, Regulatory Affair"><U>Director/Sr. Director, Regulatory Affairs</U></A></div> <div> <A HREF="id80.htm" TARGET="_top" TITLE="Associate Director, Manufacturing Ops"><U>Associate Director, Manufacturing Ops</U></A></div> <div> <A HREF="id79.htm" TARGET="_top" TITLE="Manager, Nonclinical Development Q.A."><U>Manager, Nonclinical Development Q.A.</U></A></div> <div> <A HREF="id78.htm" TARGET="_top" TITLE="Clinical Research Physician Oncology/Hem"><U>Clinical Research Physician- Oncology/Hematology</U></A></div> <div> <A HREF="id77.htm" TARGET="_top" TITLE="Clinical Research Physician Inflammation"><U>Clinical Research Physician- Inflammation</U></A></div> <div> <B><IMG BORDER="0" SRC="Symb075c00b700f0ccffff00.png" HEIGHT="16" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Quality System Application Specialist</B></div> <div> <A HREF="id87.htm" TARGET="_top" TITLE="Assoc Director DMPK"><U>Assoc Director DMPK</U></A></div> <div> <A HREF="id83.htm" TARGET="_top" TITLE="Mgr., Global Project Mgt. Admin."><U>Mgr., Global Project Mgt. Admin.</U></A></div> <div> <A HREF="id82.htm" TARGET="_top" TITLE="Project Manager Clinical Supplies"><U>Project Manager Clinical Supplies</U></A></div> <div> <A HREF="id73.htm" TARGET="_top" TITLE="M.D. Medical Safety Expert"><U>M.D. - Medical Safety Expert</U></A></div> <div> <A HREF="id64.htm" TARGET="_top" TITLE="Sr. Manager, Manager Pharmacokinetics"><U>Sr. Manager, Manager Pharmacokinetics</U></A></div> <div> <A HREF="id60.htm" TARGET="_top" TITLE="Manager/Sr. Mgr. Q.C. Laboratory"><U>Manager/Sr. Mgr. - Q.C. Laboratory</U></A></div> <div> <A HREF="id74.htm" TARGET="_top" TITLE="Investigation Mgr., Devel. Quality"><U>Investigation Mgr., Devel. Quality</U></A></div> <div> <A HREF="id47.htm" TARGET="_top" TITLE="Clinical Pharmacology Scientist"><U>Clinical Pharmacology Scientist</U></A></div> <div> <A HREF="id55.htm" TARGET="_top" TITLE="Global Product Safety Physician"><U>Global Product Safety Physician</U></A></div> <div> <A HREF="id63.htm" TARGET="_top" TITLE="Assoc. Director Global Drug Safety"><U>Assoc. Director - Global Drug Safety</U></A></div> <div> <A HREF="id61.htm" TARGET="_top" TITLE="Sr. Prin/Assoc. Dir. Biostatistics"><U>Sr. Prin/Assoc. Dir. - Biostatistics</U></A></div> <div> <A HREF="id57.htm" TARGET="_top" TITLE="Manager Regulatory Affairs"><U>Manager - Regulatory Affairs</U></A></div> <div> <A HREF="id69.htm" TARGET="_top" TITLE="Senior Director Clinical Ops"><U>Senior Director - Clinical Ops</U></A></div> <div> <A HREF="id70.htm" TARGET="_top" TITLE="Senior Research Scientist"><U>Senior Research Scientist</U></A></div> <div> <A HREF="id68.htm" TARGET="_top" TITLE="Senior Mgr., Med. Sci. Writing"><U>Senior Mgr., Med. & Sci. Writing</U></A></div> <div> <A HREF="id66.htm" TARGET="_top" TITLE="Senior Clinical Research Scientist"><U>Senior Clinical Research Scientist</U></A></div> <div> <A HREF="id67.htm" TARGET="_top" TITLE="Clinical Research Manager"><U>Clinical Research Manager</U></A></div> <div> <A HREF="id62.htm" TARGET="_top" TITLE="Clinical Trial ManagerOncology"><U>Clinical Trial Manager-Oncology</U></A></div> <div> <A HREF="id50.htm" TARGET="_top" TITLE="Clinical Research CRA"><U>Clinical Research CRA</U></A></div> <div> <A HREF="id51.htm" TARGET="_top" TITLE="Senior Director Oncology"><U>Senior Director - Oncology</U></A></div> <div> <A HREF="id54.htm" TARGET="_top" TITLE="Data Manager II"><U>Data Manager II</U></A></div> <bR> </td> <td valign="top" height=398 BGCOLOR="#FFFFCC" TEXT="#080000"> <div> <B><U>Quality System Application Specialist</U></B></div> <bR> <div> <TABLE BORDER="6" CELLPADDING="7" CELLSPACING="7" WIDTH="677" BORDERCOLORLIGHT="#660099" BORDERCOLORDARK="#660099" FRAME="BOX" RULES="ALL" HSPACE="0" VSPACE="0" > <tR> <tD VALIGN=TOP BGCOLOR=#FFFFFF HEIGHT= 869 WIDTH="226"><bR> <bR> <div> <B>Quality System Applications Specialist</B></div> <bR> <div> <B>Posted Feb.1, 2008</B></div> <bR> <bR> <div> <B><IMG SRC="0e396330.jpg" border=0 width="150" height="51" ALIGN="BOTTOM" HSPACE="0" VSPACE="0"></B></div> <bR> <bR> </tD> <tD VALIGN=CENTER BGCOLOR=#FFFFFF WIDTH="386"><div> <B>JOB DESCRIPTION: </B></div> <div> <B><U>Responsibilities will include, but are not limited to, the following:</U></B></div> <bR> <div> <IMG BORDER="0" SRC="Symb075c00b700f033000000.png" HEIGHT="16" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Maintain computer systems in compliance with policies, guidelines, and procedures.</div> <div> <IMG BORDER="0" SRC="Symb075c00b700f033000000.png" HEIGHT="16" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Assist End Users comply with  Electronic Records Management policy.</div> <div> <IMG BORDER="0" SRC="Symb075c00b700f033000000.png" HEIGHT="16" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Work with operational groups to transition existing processes to automation solutions</div> <div> <IMG BORDER="0" SRC="Symb075c00b700f033000000.png" HEIGHT="16" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Maintain application manuals and training materials</div> <div> <IMG BORDER="0" SRC="Symb075c00b700f033000000.png" HEIGHT="16" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Conduct End User training in system application use.</div> <div> <IMG BORDER="0" SRC="Symb075c00b700f033000000.png" HEIGHT="16" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Assist end users in operation of software applications (troubleshooting).</div> <div> <IMG BORDER="0" SRC="Symb075c00b700f033000000.png" HEIGHT="16" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Coordinate change requests based upon end user requirements for the software applications.   Work closely with Information Technology to design, test, document, and implement system changes. </div> <div> <IMG BORDER="0" SRC="Symb075c00b700f033000000.png" HEIGHT="16" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Manage user accounts.</div> <div> <IMG BORDER="0" SRC="Symb075c00b700f033000000.png" HEIGHT="16" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Coordinate User Acceptance Testing. </div> <bR> <div> <B>JOB REQUIREMENTS:</B> </div> <div> • <FONT SIZE="3" COLOR="#000033" FACE="Times New Roman" >BS in Computer Science or relevant discipline.  3-5 years of pharmaceutical industry experience.</FONT></div> <bR> <div> <IMG BORDER="0" SRC="Symb075c00b700f033000000.png" HEIGHT="16" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">BA or BS/MS degree in computer science or related fields.</div> <div> <IMG BORDER="0" SRC="Symb075c00b700f033000000.png" HEIGHT="16" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">1-3 years experience in Information Technology utilizing XML, SQL plus, and Crystal Reports.</div> <div> <IMG BORDER="0" SRC="Symb075c00b700f033000000.png" HEIGHT="16" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Familiarity with regulated quality systems, such as Change Control and Corrective Action Preventive Action (CAPA) Management, Customer Complaints, Training Systems, etc.</div> <div> <IMG BORDER="0" SRC="Symb075c00b700f033000000.png" HEIGHT="16" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Knowledge of cGxP predicate rules</div> <div> <IMG BORDER="0" SRC="Symb075c00b700f033000000.png" HEIGHT="16" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Knowledge of Pilgrim or Trackwise software and Learning Management Systems.</div> <div> <IMG BORDER="0" SRC="Symb075c00b700f033000000.png" HEIGHT="16" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Knowledge of computer network and security including, but not limited to, familiarity with 21 CFR Part 11, protocols, and test plans.</div> <div> <IMG BORDER="0" SRC="Symb075c00b700f033000000.png" HEIGHT="16" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Ability to interact effectively with a broad cross-section of staff. </div> </tD> </tR> </TABLE></div> <div> <B><U>The Artac Seel Company</U></B></div> <div> --Effectively Delivering Talent in Pharmaceuticals & Biotech--</div> </td> </tr></table></body>