QC Lab Operations Specialist

3 weeks ago

Monmouth Junction, United States Tris Pharma Full time

  

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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