IT POSITIONS

IT POSITIONS - Intellectt, Inc - Iselin, NJ Iselin, NJ & various unanticipated locations throughout the U.S: REGULATORY AFFAIRS SPECIALISTS: Gather & anlyz info for prod codes, device descrptn, FDA listing numbs & GMDN codes. Dsgn, dvlp, test, doc & suprt of cGxP sys asper 21CFR Part11 & US FDA. Responsible for qualfctn & valdtn (IQ/OQ/PQ), master plns, protocols, chngs requests, gap & RCA, risk mgmt plans, tracablty matrix, sumary rprts for facilities, equpmnt, sys & proceses. Prep, rvw, authorze & submisn of doc for qlty complince & regultry authorities. Skills req'd: EU MDR, ISO 13485, cGmp, IQ/OQ/PQ, MDSAP, 93/42 EEC and eCTD. Master's in Pharm Sci, Pharm, Chem or any rltd fld w/1 yr exp in job off'd or rltd occup is req'd. Validation Engineers: Dvlp & impl mfg strategies, proj mgmt, process valdtn & trblshtng. Dvlp & exec process valdtn protocols. Endure adhrnce to regultry rqmts & indstry stds. Reslv qlty rltd issues. Craft & impl robust qlty cntrl procdurs & protocols. Formulte & impl effective CAPAs. Invol in Process/Prod Valdtn & Evalutns. Compile in-process data for diff prods acc to respctd process. Initiate & trak non -routine samplng process as per request. Impl SOP at every stge & action, mntr the pass-thru process of matrl at diff airlocks, logbook doc & recognize non -routine actions. Mntr actvts in prod area, trak process & chk samplng process & run SAP query acc to req'd scope. Master's in Sci, Tech, or Engg (any) is req'd. FOR BOTH JOBS: Mail resume: HR, Intellectt, Inc, 517 Rte 1 S, Ste 1115, Iselin, NJ 08830
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