Campus Pride Jobs

Job Duties: Conduct analytical method development experiments, validation of analytical methods and testing following approved methods to test pharmaceutical products for conformance with established specifications. Perform analytical test on R&D batches and associated stability studies and generate analytical report. Conduct investigations and deviations under the supervision of a team leader and recommend solutions as needed. Prepare protocols and reports as needed for stability, method validation, comparative studies and process validation. Review specification, testing methods and test results. Conduct method verification and method transfer of validated analytical procedures as required. Maintain proper laboratory notebooks and prepare ARD/QC reports. Complies with all relevant standard operating procedures (SOP’s). Handle and test GMP stability samples by following the protocols and specified methods. Perform dissolution of tablets and capsules using USP Dissolution Apparatus I, II, III and IV. Handle and test control drug substances and manage reconciliation calculation as per DEA regulations. Perform maintenance and calibrations on laboratory instruments. Review of QC data and preparation of COA’s thereby assisting in QC release. Respond to all data reviews on a timely basis, and support management in responding to audit findings on a timely basis.Requirements: Applicant must have a Master’s degree (or US Equivalent) in Chemistry, Pharmacy or Pharmaceutical Science and two (2) years of work experience in the field of pharmaceutical quality control and analytical laboratory Or in the alternative to all the job requirements set forth above, the employer will accept a Bachelor of Science degree in Chemistry, Pharmacy or Pharmaceutical Science (or US Equivalent) and five (5) years of experience in the field of pharmaceutical quality control and analytical laboratory. Employer is willing to accept any suitable combination of education, training, or experience. Hands-on experience with analytical instruments including high pressure liquid chromatograph (HPLC), ultraperformance liquid chromatograph (UPLC), gas chromatograph (GC), ion chromatograph (IC), liquid chromatograph with mass spectrometer (LC-MS), particle size analyzer, dissolution apparatus, FT-IR spectrophotometer, UV-visible spectrophotometer, differential scanning colorimeter, thermogravimetric analyzer, and X ray diffractometer is required. Must have demonstrated experience in developing and validating analytical methods, writing analytical method development reports, validation protocols, validation reports and standard test procedures. Experience handling various pharmaceutical dosage forms including but not limited to orals solids (immediate and modified release), topicals (ointments, gels, creams, lotions and solutions) and injectables is also required. Applicant must have subject matter expertise, understanding and following FDA requirements during testing and assisting in audits.40 hours per week. 9:00am-5:00pm. Must have proof of legal authority to work in the United States.