Scientist II - (HPLC / Dissolution)
Watson Pharmaceuticals - North Brunswick, NJ

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Summary :
                                              Under general supervision, performs laboratory analyses in the testing of raw materials, in process (IP), finished products (FP), and stability (ST) samples, and performs maintenance and calibration of analytical instruments. Carries out assigned laboratory work to support method validation, development, method transfer, method comparisons and investigations. Essential Job Functions : This is not intended as a comprehensive list; it is intended to provide a representative summary of the major duties and responsibilities. Incumbent(s) may not be required to perform all duties listed, and may be required to perform additional, position-specific tasks. · Carries out responsibilities in accordance with the organization’s policies, procedures, and state, federal and local laws.
                                              · Operates general analytical instruments during raw material, in process and finished testing such as HPLC, Gas Chromatography (GC), E-tongue, Size Exclusion Chromatography (SEC), Ion Chromatography (IC), UV, automatic titrator, ICPMS, TLC, and dissolution testing and any other instrument as required.
                                              · Performs wet chemistry tests on samples such as LOD, pH, and titration; prepares standard and sample solutions as required by test methods; and performs all necessary calculations associated with the test analyses.
                                              · Labels, transcribes and records documentation such as report sheets and laboratory notebooks as required by Standard Operating Procedures (SOPs).
                                              · Cleans, maintains and calibrates laboratory equipment to ensure compliance with cGLP and cGMP.
                                              · Meets project deadlines and performance standards as assigned.
                                              · Complies with all Company policies and procedures, including safety rules and regulations.
                                              · Performs investigations and method validations.
                                              · Carries out quantitative and qualitative analyses in support of reference standard qualifications, method comparisons, method transfers and cleaning validation.
                                              · Performs related duties as assigned.
                                              . Required Knowledge and Skills :

                                              Knowledge of : · Pertinent Federal and State laws related to pharmaceutical laboratory testing, analyses and documentation.
                                              · UV, HPLC, GC, Dissolution, SEC, IC, E-tongue, ICPMS and TLC instruments operation methods and techniques.
                                              · Various commonly used softwares in analytical laboratory, for example, Empower, Chromeleon and Masslynx.
                                              · Business, scientific and personal computer hardware and software applications.
                                              · Business English usage, spelling, grammar and punctuation.
                                              · Wet Chemistry and Chemistry related to sampling methods, quality control systems, analysis and documentation practices and procedures.
                                              · FDA, USP, EP, JP, cGLP, cGMP, and SOP regulatory rules, regulations and guidelines.
                                              · Spectroscopic and chromatographic operation, techniques and systems.
                                              · Dissolution testing.
                                              · Current Company policies, practices and procedures, including safety rules and regulations.
                                              Skill in: · Performing testing accurately and precisely.
                                              · Responding to routine inquiries from management, employees and regulatory agencies.
                                              · Communicating clearly and concisely, both orally and in writing.
                                              · Analyzing problems, identifying solutions, and recommending alternate solutions.
                                              · Operating scientific and personal computers.
                                              · Managing multiple projects, duties and assignments.
                                              · Interpreting and applying Federal, state and local policies, procedures, laws and regulations.
                                              · Establishing and maintaining cooperative working relationships with others.
                                              · Complying with all Company policies and procedures, including safety rules and regulations.
                                              Physical Requirements and Working Conditions : Incumbents in this class are subject to extended periods of sitting, standing, walking, stooping, bending, lifting materials and supplies weighing up to 30 pounds, vision to monitor, and moderate to loud noise levels. Incumbents may be exposed to toxic materials, toxic gases, electrical hazards, dangerous tools and equipment. Work is performed in a laboratory environment.
                                              . Minimum Qualifications : Bachelor’s Degree in Chemistry or related science field from an accredited college or university, and three (3) years related laboratory experience, or two (2) years satisfactory performance as Scientist I.