Investigation Mgr., Devel. Quality

<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:info@artacseel.com" TARGET="_top" TITLE="mailto:info@artacseel.com"><U><B>info@artacseel.com</B></U></A></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> <bR> <bR> <bR> <div> <B><U>FULL-TIME POSITIONS</U></B></div> <div> <A HREF="id108.htm" TARGET="_top" TITLE="Director, Compliance Regulatory Affairs"><U>Director, Compliance & Regulatory Affairs</U></A></div> <div> <A HREF="id107.htm" TARGET="_top" TITLE="Scientist II, DMPK "><U>Scientist II, DMPK </U></A></div> <div> <A HREF="id106.htm" TARGET="_top" TITLE="Exec. Dir., Early Clinical Development "><U>Exec. Dir., Early Clinical Development - Inflam. & Immunology</U></A></div> <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> <A HREF="id59.htm" TARGET="_top" TITLE="Quality System Application Specialist"><U>Quality System Application Specialist</U></A></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> <B><IMG BORDER="0" SRC="Symb075c00b700f0ccffff00.png" HEIGHT="16" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Investigation Mgr., Devel. Quality</B></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>Investigation Mgr., Devel. Quality</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= 1149 ><NOBR><bR> <div> <B>Investigation Manager</B></div> <div> <B>Environmental Quality </B></div> <bR> <div> <B>Posted Feb. 26, 2007</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> <div> <B>Minimum of 5 years of </B></div> <div> <B> Experience</B></div> <bR> <bR> <div> <B>Summitt, NJ</B></div> </NOBR></tD> <tD VALIGN=CENTER BGCOLOR=#FFFFFF WIDTH="386"><div> <B>JOB DESCRIPTION: </B></div> <div> <IMG BORDER="0" SRC="Symb075c00b700dc33000000.png" HEIGHT="15" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Manage Celgene Investigation Function: Directly supervise the QA Investigation Coordinator and other individuals responsible for the review, approval, tracking and trending of laboratory investigations, deviations and associated CAPAs at Celgene. Oversees the Investigation function. Reviews investigations and collaborates with the investigation writer (owner) to ensure that investigations are in conformance with established SOPs, and are clearly written and complete. Provides decisions on investigation classifications. Notifies senior management as required by site procedures. Tracks and reports on status of investigations/deviations and CAPAs to ensure completion according to established timelines. Trends investigations and CAPAs and provides reports to management. </div> <div> <IMG BORDER="0" SRC="Symb075c00b700dc33000000.png" HEIGHT="15" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0"> Compliance Systems: Develops, implements and maintains the activities of the Investigation function in compliance with cGMPs, SOPs, good documentation practices and safety standards in accordance with corporate, regulatory and timeline expectations. </div> <div> <IMG BORDER="0" SRC="Symb075c00b700dc33000000.png" HEIGHT="15" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Vendor Contacts: Communicates, when necessary, with outsourced manufacturing and analytical service providers regarding deviations and investigations conducted at the vendor site. Tracks and trends vendor investigations. </div> <div> <IMG BORDER="0" SRC="Symb075c00b700dc33000000.png" HEIGHT="15" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Human Resources: Diagnoses and defines work team needs for effective performance. Assists in the recruiting of qualified employees. Develops internal talent through coaching, counseling, training and other relevant experiences that meet the needs of the organization. Sets performance objectives and regularly evaluates employee performance to ensure they are meeting both current and future needs. Communications: Maintains productive communications with staff, internal colleagues in Quality Control, Quality Assurance, AR&D, Technical Operations, and Regulatory Affairs and senior management as needed to properly maintain the Investigation function and the timely completion of investigations and CAPAs</div> <bR> <div> <B>JOB REQUIREMENTS:</B></div> <div>  </div> <div> <IMG BORDER="0" SRC="Symb075c00b700dc33000000.png" HEIGHT="15" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">BS/MS in Analytical Chemistry or relevant scientific discipline </div> <div> <IMG BORDER="0" SRC="Symb075c00b700dc33000000.png" HEIGHT="15" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">5+ years experience within QC and/or QA function in pharmaceutical industry </div> <div> <IMG BORDER="0" SRC="Symb075c00b700dc33000000.png" HEIGHT="15" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">2+ years experience conducting investigations in the pharmaceutical industry </div> <div> <IMG BORDER="0" SRC="Symb075c00b700dc33000000.png" HEIGHT="15" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Thorough knowledge of cGMP in the pharmaceutical industry Knowledge and application experience with investigation and root cause analysis tools and methodology </div> <div> <IMG BORDER="0" SRC="Symb075c00b700dc33000000.png" HEIGHT="15" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Good computer skills and working knowledge of common business software</div> <div> <IMG BORDER="0" SRC="Symb075c00b700dc33000000.png" HEIGHT="15" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Excellent organizational skills </div> <div> <IMG BORDER="0" SRC="Symb075c00b700dc33000000.png" HEIGHT="15" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Excellent problem-solving, verbal and written communication skills </div> <div> <IMG BORDER="0" SRC="Symb075c00b700dc33000000.png" HEIGHT="15" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Must have strong interpersonal and communication skills, be a team player </div> <div> <IMG BORDER="0" SRC="Symb075c00b700dc33000000.png" HEIGHT="15" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Must be an individual with proven initiative and demonstrated accountability Professional integrity and maturity are required</div> <bR> </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>