QC Chemist I

Job Description Ø Position Summary for QC Chemist I: o Perform basic wet chemistry test for reagent chemicals in accordance with QC non-compendial Standard Operating procedures Operate AA, pH meter, FTIR, Melting Point apparatus, Specific Rotation, Conductivity and other relative basic lab instruments to conduct analytical testing. o Document into QC laboratory notebook and Analytical report according to Good Documentation practices (GDP) guidelines. Strong knowledge of ISO and cGMP guidelines. Ø Key Responsibilities: * QC Chemist is responsible to conduct analytical testing using basic wet chemistry, instrumentation techniques for Reduced testing and Lot controlled Bulk, finish goods and stability samples. Perform analytical testing such as Identification, Acid-base Titration, Standardization of normal solutions and buffers as per current laboratory SOPs, and ACS/USP/FCC/EP/BP/JP monographs. * Conduct analytical testing using basic wet chemistry instruments such as AA, FTIR, pH meter, Melting Point, Polarimeter, Conductivity meter etc. in accordance with laboratory SOPs, and ACS, USP/FCC/EP/BP/JP monographs. * Document and report analytical testing data and results in a laboratory notebook following good documentation practices. Enter analytical testing results into the LIMS per applicable SOP. * QC chemist is responsible to perform all the Instrument verifications at the required intervals, document into logbook and serve as a backup to lab technician for daily and weekly verifications * QC chemist is responsible to prepare all the test reagents and test solutions used in analytical testing according the applicable SOPs, Document preparation into respective laboratory notebook and assigned expiration date as described in the procedure. Label the reagent and test solutions according to the procedure, enter the information into the reagent and chemical tracking log and store appropriately in the lab. Manage the Reagent and Chemical inventory log on regular basis. * QC Chemist is responsible for Managing, Ordering, Receiving lab supplies, reagents and chemicals on regular basis. Creates Requisitions/Purchase Orders in AS400 system for laboratory reagents, supplies and external laboratory testing, and seek required approval for the purchase orders. Receives purchase orders in the AS400 system. Receives, Labels and stores chemicals, reagents and lab supply appropriately in the chemical storage room and or designated area. * QC Chemist is responsible for External lab testing program. With the help of lab tech, chemist prepares samples, sample submission forms, submits the sample to the shipping department on regular basis and tracks sample into the External lab testing log. Work side by side and follow through with external lab to resolve any issues. Receives results from external lab, Reviews data for GDP, lab and technical errors, report results on Analytical Report and LIMS, then submit for approval. * QC chemist is responsible to update and maintain QC equipment logbook, QC Electronic sample log, Reagent Inventory log and External testing log on daily basis. * Maintain general lab housekeeping, Efficiency, productivity and Integrity with analytical data to meet required standards. Assist in continuously updating standard operating procedures. Perform elementary method analysis and development for troubleshooting purposes. Make recommendations to technical support on analytical methods. Assist with resolution of Investigations, customer complaints and reviewing batch records. * QC Chemist is responsible to maintain and improve Safety and Quality for the department. Represent QC laboratory for Gemba, Inspections related to Safety and Quality. Manage and handle labeling glassware, solutions and waste chemicals on regular basis in accordance with company procedure and policy for Safety and Quality. Segregate, label and dispose of Laboratory waste and reagent chemicals in accordance with company, local, state and federal regulations and assist in reducing waste. * Empty out sink tank into a waste drum twice a week or as needed to support analytical testing. * QC chemist is responsible to participate in Customer, ISO, and Internal Audit and assist with the preparations for audit readiness. Knowledge of ISO, FDA, DEA and cGMP regulations. * Train fellow chemist and QC lab technician on relative tasks. * Adheres respect for colleagues, good communication, multi-tasking, Organization and Problem-solving skills. Knowledge and experience with Quality systems such as LIMS, Trackwise and Agile. Familiar with Microsoft office such Excel, Word, Access, and outlook databases. * Knowledge of Lean Six Sigma Process and support continuous improvement activities. Knowledge of Microsoft Office suite. * Support Senior Chemist, and Team lead as needed. Perform other duties as assigned by the Supervisor. Serve as a backup for fellow lab technician and Chemist II. Ø Minimum Requirements/Qualifications: * Associate degree in chemistry or related life science with 2-3 years of laboratory experience or bachelor's degree in Chemistry or related life science and 1-3 years of laboratory experience. * Proficient to read and interpret documents such as procedure manuals, operating and maintenance instructions, drawings, specifications, safety rules and guidelines, etc. * Capable to follow current Monographs, ISO and cGMP standards. * Capable to work individually and in team setting. Highly organized and detail oriented with effective time management skills. * Capable to prioritize and multi-task critical assignments and communicate cross-functionally * SURGE100 * TFSEarlyTalent2021

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