Good company to work for.
• Conduct testing of in-process, release, and stability of Drug substance products by GC, RP-HPLC,
SEC-HPLC, CEX-HPLC, SDS-PAGE Silver Stain, Coomassie Blue, Plasmid Restriction Map, UV, and pH.
• Review analytical data, reagents, and standards against acceptance criteria.
• Perform laboratory investigations and deviations for OOS/OOE/OOT.
• Participate with assay transfer and assay validation.
• Assist in troubleshooting problems on lab instruments and analytical methods.
• Write protocols and reports under supervision.
• Author of expiration date extension/trending reports for Reference, Controls, and Critical Reagents.
• Conduct data audit for technical reports
• Train and mentor lab associates on analytical methods, techniques, and review of analytical reports.
• Support internal and external audits.
• Actively participate in group and project teamwork to optimize process improvements (5S,Test Report Forms, Log-In Forms, Test Methods and SOPs revision).
• Ensure conformance to specifications and GMPs and meeting scheduled performance of 95% on time
• Execute equipment qualification (ie, executing IQ/OQ/PQ on 5 Agilent Technologies 1200 Series
HPLC Systems and Agilent GC 6890Series/Headspace G1888).