QC Lab Operations Specialist
3 weeks ago
QC Lab Operations Specialists for Tris Pharma, Inc. to work at our Monmouth Junction, NJ loc. Perform duties to accord w/ company policies + procedures, SOPs, + state, federal + local laws. Test raw materials, In-process, extended release Intermediates, Finished Product + Stability samples, incl dissolution, assay, preservatives, Related Compounds analysis, content/blend uniformity, particle size distribution by Laser Diffraction/Sieve Analysis, Bulk + Tapped density, cleaning verification/validation according to analytical methods, United States Pharmacopeia (USP) procedures in GMP-regulated lab environment. Analyze + interpret test results. Operate analytical instruments incl High-Performance Liquid Chromatography (HPLC), Ultra Performance Liquid Chromatography (UPLC), Gas Chromatography (GC), Ultra Violet Visible Spectroscopy (UV/Vis), Karl Fischer, moisture balance, automatic titration, Infra-Red Spectroscopy (IR), Malvern Particle size analyzer, Thin Layer Chromatography (TLC) + Dissolution Apparatus (Distek). Initiate + draft investigations. Create, review + revise SOPs. Assess equip. perf. Execute equip. qual. protocols. Train + mentor chemists on instrument oper. + maint. Eval instrument perf. + troubleshoot instrument malfunction. Process + report calibration results using instrument specific data processing software. Complete timely compendial review to maintain QC lab compliance, + work w/ rel departments (AR&D + MV) on compendial review actions. Assist lab investigations + root cause determinations. Write/review investigation reports. Initiate, execute + track CAPAs in QC lab. Identify recurring events + trends w/in QC investigations/CAPAs to propose imprvmnts. Troubleshoot probs assoc. w/ instrumentation, analytical anomalies, + lab investigations. Meet pjct deadlines + perf. standards. Adhere to cGMPs + cGDPs. Occasional weekend and night shift work. Requirements
Must have Master’s in Chem, Pharmacology, or rel sci field and 3 yrs laboratory exp in pharmaceutical industry with cGMP requirements. Also req the following skills (3 yrs exp in): handling extended release intermediates, extended release oral suspensions and extended release powder for suspensions; performing and interpreting analytical results and performing laboratory investigations; analytical method verifications and method transfers; performing routine metrology, calibration, maintenance and troubleshooting of analytical instrumentation in QC and cGMP laboratories. Alternatively, must have Bach’s in Chem, Pharmacology, or rel sci field and 5 yrs laboratory exp in pharmaceutical industry with cGMP requirements. Also req the following skills (5 yrs exp in): handling extended release intermediates, extended release oral suspensions and extended release powder for suspensions; performing and interpreting analytical results and performing laboratory investigations; analytical method verifications and method transfers; performing routine metrology, calibration, maintenance and troubleshooting of analytical instrumentation in QC and cGMP laboratories. Any suitable combination of education, experience, or training will be accepted.
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QC Lab Operations Specialist
2 weeks ago
Monmouth Junction, New Jersey, United States Tris Pharma Full timeQC Lab Operations Specialists for Tris Pharma, Inc. to work at our Monmouth Junction, NJ loc. Perform duties to accord w/ company policies + procedures, SOPs, + state, federal + local laws. Test raw materials, In-process, extended release Intermediates, Finished Product + Stability samples, incl dissolution, assay, preservatives, Related Compounds analysis,...
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