Our number 1 priority is to pioneer patient access to better healthcare. We are a company of firsts. 1st to develop an oral penicillin antibiotic. 1st to develop and launch biosimilars. 1st to launch an FDA-cleared digital therapeutic. And we never stop asking: how can we continue to pioneer access in an ever-more digital and global world? The Quality Control Analyst Specialist is responsible for complying with the company's Quality Control efforts. This includes the performance of area responsibilities necessary to ensure that Laboratory activities are in accordance to SOPs, cGMPs and FDA requirements and are consistent with laboratory objectives. Under the direction of the Manager/ Supervisor, may supervise and give direction to others. Your responsibilities include, but are not limited to: * Proficiently conducts more technically advanced analyses (e.g. degradation assays, R&D stability studies) concerning chemistry of drug products, raw materials, components and processes for purposes of product and process development, quality control, quantitative and qualitative analysis. * Perform analytical testing to ensure compliance with FDA and cGMP requirements according to approved written procedures and specifications. * Instrumentation includes those of a high level of complexity and difficulty (e.g. GC and HPLC) * Prepares test data for appropriate review. * The individual should be self-motivated with a well-developed knowledge of HPLC/GC problem solving and troubleshooting. * Adheres to all applicable procedures, cGMP's, company policies, and all other quality or regulatory requirements (OSHA, DEA, FDA, HS&E, etc.). Ensures all work is performed in a safe, effective manner, and in compliance with the appropriate industry and regulatory (FDA, DEA, OSHA) standards, and Departmental, Plant, and Corporate quality and Behavioral Based Safety (BBS) goals. * Monitors for and promotes Quality Culture and Novartis Behaviors for increased customer/quality focus. * Quality Management, as required, may assign and require other duties and responsibilities not previously mentioned above.
Note: This position may require the labeling, packaging or movement of hazardous (flammable, corrosive, toxic, etc.) waste within the facility. If so, this employee would be trained under OSHA's HAZWOPER standard, 29 CFR 1910.120 as an 8-Hour first responder, 24-Hour incident commander, or a 40-Hour incident commander. * In lieu of HAZWOPER training, the employee will receive training on the requirements of the Resource Conservation and Recovery Act pursuant to 40 CFR 265.16. * All employees that have received the above-mentioned training upon hire will receive annual refresher training that covers the OSHA HAZWOPER standard and the requirements of RCRA. * To perform this job successfully, an individual must have satisfactory visual acuity and color perception. Visual acuity and color blindness screenings may be used to screen applicants. * Satisfactory visual acuity means at least 20/20 vision, corrected or uncorrected. * Satisfactory color vision means ability to recognize traffic signals and devices showing the standard red, green, and amber traffic signals.