QC Chemist I & II

Company: ProStaff Solutions Inc
Location: New Brunswick
Posted on: May 8, 2022

Job Description:

ProStaff Solutions is looking for QC Chemist I & II to work with a pharmaceutical company in New Brunswick, NJ. Direct Hire Job Summary: Perform analytical testing for raw materials and various drug products in different dosage forms such as tablets, capsules, transdermal patch etc. Operate instruments such as HPLC, GC, Dissolution, UV-Vis, FTIR, Particle Size Analyzer, KF Titrator, Oven etc. Area of Responsibility Performs tests and analysis of raw materials, bulk and finished products, scale-up samples, process validation samples, cleaning validation samples, and stability samples using instrumentation such as HPLC, UPLC, GC, UV-Vis, FTIR, dissolution apparatus, particle size analyzer etc. Responsible for the timely execution of lab analysis as directed. Assists in conducting analytical method validation and method transfer activities, as directed. Concurrent documentation of all the raw data, observations in the notebooks or equivalent electronic system as per Good Documentation Practices. Provides training and mentoring to less experienced chemists, as needed. Be vigilant to any difficulties, undesirable/unacceptable problems in analytical method execution, chromatography, and data integration and keep the supervisor/manager informed of such issues. Help lower level chemist to resolve technical issues. Compile the analytical data and notify the results to supervisor/manager. Adhere to safety, DEA procedures and department SOPs. Keep the working place clean and tidy. Supports systems to ensure the successful completion of Departmental goals and objectives. Assists Metrologists in laboratory equipment qualifications, calibrations and preventative maintenance programs, as needed. Assists in preparing technical documentation including test reports, analytical test procedures, and change controls, investigations and CAPAs as needed. Manages USP reference standards and the qualification of secondary standards, as needed. Works to ensure compliance with cGMP's and the site operating procedures under the direction of senior staff or laboratory management. Works independently and the primary job functions require independent judgment. Participates in a leadership capacity, in one or more of several laboratory committees, (e.g. Safety, Instrumentation, GMP, SOP etc.) Performs other duties as assigned. Education or Equivalent: Minimum BS or equivalent degree in Chemistry or related scientific discipline. Experience: 5+ years of experience in pharmaceutical analytical laboratory People based qualities: Good communication and writing skills, respect to others, positive attitude, team work, quick learner. Requirements and Qualifications: Familiarity with analytical instrumentation theory such as HPLC, GC, FTIR, UV and practice. Familiarity with wet chemistry techniques. Ability to train junior chemists. Working knowledge of Microsoft Office Applications. Knowledge of ICH and FDA regulatory guidance. Must be familiar with cGMP/GLP concept or practices for analytical laboratories and EHS/OSHA safety regulations. Familiar with of USP dissolution apparatus 1 and 2. Excellent written and verbal communication skills.

Keywords: ProStaff Solutions Inc, New Brunswick , QC Chemist I & II, Other , New Brunswick, New Jersey