2 jobs found in Sayreville, NJ

Sr. Scientist, Statistical Programming-Rahway, NJ: Suport centrlzd mangmnt of tech, pltfrms, inspctns & rltd proces & training f/globl Statstcl Prgrmng orgnztn to ensre it oprts in cmplianc w/deptmntl & cmpny SOPs, rgultry reqs, & stndrds. Reqd: Master deg in Comp Sci, Statstcs, Aplied Math, IT, Life Sci, Engg, or rltd + 2yrs in clincl trial envrnmnt (Anlysis & Rprtng, IT, Data Mngmnt) in pharma indstry &3 yrs SAS or R prgrmng exp OR Bachelr deg in Comp Sci, Statstcs, Aplied Math, IT, Life Sci, Engg, or rltd + 5yrs in clincl trial envrnmnt (Anlysis & Rprtng, IT, Data Mngmnt) in pharma indstry & 3yrs SAS or R prgrmng exp. Hv Busnes Anlyst exp. Cmprhnsv knwldg of rprtng prceses (SOPs) algn w/rgultry reqs (21 CFR Prt 11, ICH GCPs) & SDLC; Stat, Clncl, Medcl Montrng & Data Mngmnt concpts; knwldg of clncl trials proceses, data structrs & corespndng tools to mnge, extrct, anlyze & rprt data. knwldg & exp in dvlpng anlysis & rprtng...

CHEMISTS Fairfield, NJ / Duties: Conduct qualitative & quantitative chemical analyses or exprmnts for quality or process control. Dvlp analytical methods for successful charactrizatn of drug substance & products. Implmnt & monitor quality assurance systems & procedures. Implmnt CGLP/CGMP, maintain compliance w/regulatory reqts, review quality documents, implmnt standard oprtng procedures, guidelines & procedures, & review & approve OOS & OOT documents. Review specs & test procedures rltd to raw materials, packaging materials & finished products. Reqts: Mstrs deg or equiv in Chem, Biotech or rltd field w/min 3 yrs exp in job offered or related occup such as GM or Head Quality Assurance. A baccalaureate deg w/5 yrs post-baccalaureate, progressive exp is ok for Mstrs equiv. Any suitable combo of educ, training, or exp is ok. Sal: $114,483.00. Mail resume w/proof of work elig to: Attn: HR, Stira Pharmaceuticals LLC, 161 Dwight Place, Fairfield, NJ...