QC Senior Chemist

The Quality Control (QC) Senior Chemist position supervises a small group of laboratory chemists who are responsible for conducting analysis of pharmaceutical dosage forms (OTC)/ Dietary Supplements and raw materials utilizing HPLC, GC, dissolution testing, spectroscopic and wet chemistry techniques. The QC Senior Chemist assists Supervisor and Manager in planning the daily work and subsequent tasks of this team to ensure the analysis of stability samples and/or finished drug products meets all quality criteria and business delivery timelines. The QC Senior Chemist helps Supervisor and Manager in managing the workload of the team and ensures samples received in the QC laboratory are properly prepared and tested in a timely manner. Provides oversight of the Chemists within their group, the testing methods of pharmaceutical dosage forms (OTC)/Dietary Supplements and raw materials to ensure that the proper quantitative analysis is conducted upon receipt of pharmaceutical raw material and finished products within the Quality Control Laboratory. ESSENTIAL FUNCTIONS Coordinates with other QC Supervisors and laboratory management so that the shared resources such as laboratory instruments, reagents, etc. are available for assigned staff to perform their job duties effectively and efficiently. Performs the pharmaceutical OTC & Dietary supplement analysis to support OTC & Dietary Supplement manufacturing which includes assay, impurity, dissolution testing, content uniformity, and physical testing. Conduct analysis in compliance with cGMP requirements, compendia standards, and internal procedures. Maintain accurate record of analysis and perform documentation to company standards. Perform laboratory analysis right first time, contemporaneous documentation, analyze and document the results. Notify manager immediately of nonconforming data or unexpected occurrences. Reviews and analyzes the stability samples and associated analytical data, prepares or assists in preparing Stability Summary Reports for Annual Product Review Reports. Reviews/Checks of analytical data by following test methods/SOPs. Performs operational qualification on analytical instruments, analytical method verification/validations, validation protocols and reports for analytical methods. Conducts laboratory investigation (OO5/OOT) under the supervision of laboratory management. Organize work schedule to complete assigned tasks efficiently and on schedule. Work under direction provided by supervisor and other duties as assigned. Assist in Training and monitoring of the new hires (trainees) in learning or performing basic skills and assists in evaluating the need of any potential equipment for laboratory. Ensures the laboratory is kept in a safe working environment and in compliance with OSHA and other laboratory safety standards. Maintains knowledge of the latest guidelines of regulatory requirements of International Conference of Harmonization, USP, USFDA and OSHA. Complies with all regulatory/in-house requirements may include but not be limited to safety, housekeeping, laboratory chemical waste, cGMP, cGLP, documentation. Assists in compilation of regulatory documents. Managing the Pharmacopeia changes and upgrades and implementing the same after upgrading the change repeated documents through proper channels of change control and training to all concerned. EXPERIENCE AND QUALIFICATIONS To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the experience and education required. EDUCATION & EXPERIENCE Bachelor's degree in Chemistry or related science field with eight (8) to ten (10) years lab experience in a pharmaceutical chemical or related industrial experience; preferably solid dosage forms manufacturing. Method Development experience is preferred. Master's degree or higher with six (6) to eight (8) years of progressive lab experience in a pharmaceutical chemical or related industry; preferably generic pharmaceuticals. Method Development experience is preferred. Demonstrated skills and experience in leading a group of QC Chemists. COMPUTER SKILLS Requires a strong knowledge of algebra, calculus and statistics and how they are applied. Math skills commensurate with scientific background are required. KNOWLEDGE, SKILLS AND ABILITIES To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills and abilities required. INDUSTRY KNOWLEDGE Knowledge and experience of applicable FDA regulatory standards and requirements for solid oral dosage manufacturing required. Knowledge of analysis of pharmaceutical dosage forms and raw materials utilizing HPLC, GC, ICP-MS, UV, TLC, dissolution testing, spectroscopic and wet chemistry techniques is a plus. COMMUNICATION SKILLS Advanced level of written and verbal communication skills with the ability to read technical procedures or governmental regulations. Ability to write reports and required documentation. REASONING ABILITY Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram or schedule form. Must possess initiative and troubleshooting ability.

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