TECH PROFESSIONALS - Katalyst Healthcares & Life Sciences : Job Details

Untitled TECH PROFESSIONALS - Katalyst Healthcares & Life Sciences Inc. - So. Plainfield, NJ So. Plainfield, NJ & various unanticipated locations throughout the U.S. QUALITY ANALYSTS: Invlv in dsgn, dvlpmt, implmnt, test, doc & supp of cGxP sys as per 21 CFR Part 11 & US FDA. Resp for qualfctn & vldtn (IQ/OQ/PQ), master plans, protocols, chnge req, gap & root cause anlys, risk mgmt plans, traceability matrix, sumry rprts for facilities, equip, sys & process. Prep, revw, authrze & submssn of doc for qlty cmplnce & regltry authorities. Master's in Sci, Pharma, Biotech, Chem, Biochem, Chem Engg, Mech Engg, Industrial Engg, Biomed Engg, Regulatory Affairs or rltd fld w/6 mos exp in job offr'd or rltd occup req'd. CLINICAL DATA ANALYSTS: Prfrm all aspects of data mgmt, stat progmmng, anlys & rprtng of clin data delvrbls. Crte approprte dbs, datasets. Data valdtn, discrpncy mgmt, extrctn & db lock. Dvlp, rvw & mnge key study docs like data mgmt & vldtn plans, stat anlys plans (SAP), protocols, CRF, TMF, SAE, SOPs & their audit. Prfrm QC/vldtn of Clnicl Dvlpmt actvts like UAT, edit checks, SAS progmd checks, data review, coding, lock process. Create TLG. Master's in Sci, Pharma, Biotech, Clin Research, Medicine, Dentistry, Biochem, Regulatory Affairs, Health Informatics, Info Sys Engg & Mgmt or rltd fld w/6 mos exp in job offr'd or rltd occup req'd. BOTH JOBS: Mail resume: HR, Katalyst Healthcares & Life Sciences Inc., 285 Durham Ave, Ste 12, So. Plainfield, NJ 07080 recblid exseg7xg8ibrx767uoy7vwqgtu2fgc