Senior QC Analytical Specialist
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POST DATE 9/16/2016
END DATE 10/15/2016
Engineering Resource Group, Inc.
Florham Park, NJ
JOB DESCRIPTIONResponsible for the development, validation and execution of analytical and wet chemistry methods including HPLC, FTIR, GC, and UV/Vis using cGMP standards and practices. Conduct quality control functions using analytical methods including for in-process materials, final products, raw materials, clean utilities samples, finished goods, and stability samples. Position is with a growing biopharmaceutical company in Northern NJ. Specific responsibilities include:- Develop qualification protocols for new QC equipment and instrumentation and ensure compliance.- Ensure equipment complies with procedures and specifications by reviewing qualification and maintenance records. Develop documentation and technical reports for procedures.- Compile and analyze data.- Provide training to junior analysts and scientists. Assist in troubleshooting, laboratory investigations and problem resolution. - Maintain HPLC and GC and other laboratory equipment.
- Biology, Biochemistry or chemistry or other science degree. MS preferred
plus at least 4 years of pharmaceutical / biotech industry experience.-
Expertise in cGMP and GLP regulations with knowledge of USP and compendial
requirements.- Experience with GLIMs, Oracle, TrackWise, Empower or other
computerized laboratory data storage systems- Excellent organization, communication,
and problem solving skills. - Experience in presenting technical data to
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